Methods and Devices for Treating Sleep Apnea and Snoring

ABSTRACT

A method for treating a breathing disorder, the method includes providing a tissue retractor that has a shaft having a first end and a second end, an anchor member attached to one of the first end or the second end, and a retractor member attached to the other of the first end or the second end, and inserting the shaft through a soft tissue of a patient&#39;s soft palate, wherein the tissue retractor distributes a force on the soft palate thereby changing a size, a stiffness, and/or a shape of the patient&#39;s soft palate and preventing obstruction of the patient&#39;s airway.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/672,019, Feb. 6, 2007, which is a continuation-in-part of U.S. patentapplication Ser. No. 10/597,590, filed Jul. 31, 2006 (now U.S. Pat. No.8,925,551), which is a national stage filing, under 35 U.S.C. § 371 ofInternational Patent Application No. PCT/US2005/006430, filed Feb. 28,2005, which claims the benefit of U.S. Provisional Patent ApplicationNo. 60/547,897, filed Feb. 26, 2004. U.S. patent application Ser. No.10/597,590, filed Jul. 31, 2006, also claims the benefit of U.S.Provisional Patent Application No. 60/765,638, filed on Feb. 6, 2006.All of these priority applications are hereby incorporated by referenceherein.

FIELD OF THE INVENTION

This invention relates to methods and devices for maintaining upperairway patency.

BACKGROUND OF THE INVENTION

Snoring, upper airway resistance syndrome, and obstructive sleep apneasyndrome (OSAS) are all related to narrowing or obstruction of the upperairway during sleep (sleep disordered breathing). According to theNational Institutes of Health (NIH), approximately 18 million Americanshave sleep apnea (sleep disordered breathing), but fewer than 50% arepresently being diagnosed. According to the National Highway Traffic andSafety Administration (NHTSA), 100,000 accidents and 1,500 trafficfatalities per year are related to drowsy driving. More than 50% ofAmericans over age 65 have sleep difficulties, and prevalence of sleepproblems will therefore increase as the over-65 population increases.Each year, sleep disorders, sleep deprivation, and excessive daytimesleepiness add approximately $16 billion annually to the cost of healthcare in the U.S., and result in $50 billion annually in lostproductivity.

Pathophysiology of Sleep Disorders

Sleep disorders are largely caused by too much soft tissue in thethroat. Humans are unique because their upper airway has a curved shape,an anatomical change that is related to the evolution of human speech.As a result the upper airway of humans is more flexible than that ofother species and is more prone to collapse under negative pressure. Inthe awake state a certain amount of tone is present in upper airwaymuscles to prevent this collapse. However, during sleep muscle tonedecreases in upper airway muscles and in certain susceptible individualsthis relaxation allows the airway to collapse (Horner R L. Motor controlof the pharyngeal musculature and implications for the pathogenesis ofobstructive sleep apnea. Sleep 1996; 19: 827-853).

The upper airway refers to the air filled spaces between the nose andthe larynx (FIG. 1). The most relevant part of the upper airway forsleep disorders is the air cavity at the back of the throat called thepharynx. The pharynx can be divided into three anatomical levels (FIG.2):

1) The nasopharynx is the part of the pharynx in the back of the nasalcavity.

2) The part at the back of the mouth is called the oropharynx. To bemore precise it is best called the velopharynx. This level correspondsto that part of the pharynx containing the velum (soft palate) andtongue curve.

3) The hypopharynyx is behind the tongue base.

The velopharynx is more susceptible to collapse because there are moresoft tissue structures, leaving less room for airflow. The majorstructures of the velopharynx are the soft palate and the tongue, bothof which are very flexible. The soft palate acts as a barrier betweenthe mouth and the nose. In many people it is longer than necessary andextends down between the tongue and pharyngeal wall. The tongue is thelargest muscular organ of the upper airway and is anatomically divisibleinto a blade, body and base (FIG. 3). Most of the tongue's curve is atthe junction of the tongue body and base.

In the awake condition the structures of the velopharynx maintain theirshape because of continuous tone of their internal muscles. When thistone decreases, such as during sleep, these structures become quiteflexible and distensible. Without the normal muscle tone that keeps themin place, they tend to collapse at relatively low negative pressures.Although muscles relax throughout the body during sleep many of therespiratory muscles remain active. Specifically the major muscle thatpulls the tongue forward, the genioglossus muscle, has been reported toshow normal or increased activity during obstructive apneas. Normallythe genioglossus is capable of moving the tongue forward and evenprojecting it out of the mouth. Why the genioglossus muscle sometimesfails to prevent obstructions has not been explained.

During inspiration the chest wall expands and causes negative pressureto draw air into the nose and mouth and past the pharynx into the lungs.This negative pressure causes upper airway soft tissue to deform,further narrowing the airway. If the airway narrows enough the air flowbecomes turbulent causing the soft palate to vibrate. The vibration ofthe soft palate produces the sound known as snoring. Snoring isextremely common effecting up to 50% of men and 25% of women. By itselfsnoring is not a medical problem although it can be a tremendous problemfor the patient's bed partner and a major cause of marital strain.

A small amount of decreased airflow or brief obstructions occur in allhumans during sleep. These episodes are counted as medically significantif airflow is decreased more than 50% of normal (hypopnea) or if airflowis obstructed for more than 10 seconds (apnea). The number of apneas andhypopneas that occur during each hour of sleep is measured to diagnosethe severity of the sleep disorder. These episodes of hypopnea or apneaoften cause some degree of arousal during sleep. Although the patientdoes not awaken to full consciousness, the sleep pattern is disturbedcausing the patient to feel sleepy during the day. If the frequency ofhypopnea or apnea is more than 5 episodes an hour it is called upperairway resistance syndrome. These patients often show symptoms relatedto the sleep disruption. Specifically, these patients are excessivelysleepy during the day. In addition more subtle symptoms such asdepression and difficulty in concentrating are also commonly reported.

Technically the diagnosis of OSAS is defined as an average of more than10 episodes of hypopnea or apnea during each hour of sleep. Although theairway is obstructed the patient makes repeated and progressively moreforceful attempts at inspiration. These episodes are silent andcharacterized by movements of the abdomen and chest wall as the patientstrains to bring air into the lungs. Episodes of apnea can last a minuteor more, and during this time the oxygen levels in the blood decrease.Finally, either the obstruction is overcome, usually producing a loudsnore, or the patient awakes with the feeling of choking.

Very common symptoms in OSAS patients are morning headaches and acidreflux. During airway obstructions the forceful attempts to inspire aircan cause tremendous negative pressure in the chest. These high negativepressures can draw acid up the esophagus from the stomach. The acid cantravel all the way into the mouth and cause inflammation of the vocalcords and nasal mucosa. The presence of the acid in the upper airwaycauses reflex bronchoconstriction in the lung that is similar to anasthma attack. If even a small amount of acid enters the lung it cancause the vocal folds to close tightly and itself cause a prolongedapnea called laryngospasm. In many patients the repeated stretching ofthe espophageal sphincter causes chronic changes and these patients canhave acid reflux during the day.

Most importantly, sleep disorders can cause serious medical disordersand death. Apneas cause a large strain on the heart and lungs. Over timethe many repeated episodes of apnea cause chronic changes leading tohypertension. Long periods of apnea allow the oxygen levels in the bloodto decrease. In turn the low oxygen can cause heart attacks or strokes.

Treatment of Sleep Disorders

Although OSAS occurs in both children and adults the cause and treatmentis very different. OSAS in children almost always occurs when the childhas large tonsils, and tonsillectomy cures the condition. Tonsilsnaturally decrease in size with age and are rarely a problem in adults.Instead susceptible adults usually have enlargement of their tongues,soft palate and/or pharyngeal walls. This enlargement is mostly due tofat deposits within these structures.

Adult sleep disorders are difficult to treat for a variety of reasons.The upper airway is a very mobile structure that performs the criticalfunctions of swallowing and speech. These functions are easilycompromised by surgical procedures or other interventions. In addition,the upper airway also has a large amount of sensory innervation thatcauses reflex gagging and coughing. Theoretically a physical stent thatis placed in the oral cavity and pharynx would be completely effectivein relieving sleep apnea. When a patient is totally unconscious, such aswhen they are anesthetized for surgery, the airway can be stented openby placing a curved oral tube into the mouth and pharynx. In addition,endotracheal tubes establish a secure airway for artificial ventilation.However, after anesthesia wears off, patients immediately sense andreact to the foreign objects in their throats and expel them. Thereforedevices such as oral and endotracheal tubes, or anything similar, cannotbe used for the treatment of OSAS.

Although physical stents cannot be used for OSAS an indirect way ofstenting the upper airway with positive air pressure is the most commonprescribed treatment for OSAS. This method is called continuous positiveairway pressure (CPAP). CPAP requires the use of a mask tightly attachedaround the nose and connected to a respirator. The exact amount ofpositive pressure is different for each patient and must be set byovernight testing using multiple pressures. The positive pressure actslike a stent to keep the airway open. CPAP is not a cure but a therapythat must be used every night. Although many OSAS patients are helped byCPAP it is not comfortable for the patient or their bed partner.Patients often cannot tolerate the claustrophobic feeling of a masktightly attached to their face. In addition there are often manytechnical problems with maintaining a proper seal of the mask to theface. For these reasons up to half of all patients who are prescribedCPAP stop using it within 6 months (Sanders, “Medical Therapy for SleepApnea,” Principles and Practice of Sleep Medicine, 2nd Edition, pp.678-684).

Tracheotomy

The only completely effective surgical therapy for OSAS is to bypass theentire upper airway by performing a permanent tracheotomy, a surgicalprocedure that forms a direct connection to the trachea through theneck. This is a dangerous procedure reserved for the worst cases whenthere is a high risk of serious medical complications from OSAS.Notably, temporary tracheotomies are often performed on patients withsevere OSAS to control the airway before any other procedure isperformed on their upper airway. The reason is that these patients areat high risk of acute airway obstruction and death if there is anyswelling in their airways. Due to the tremendous excess of swollentissue in their upper airways OSAS patients are very difficult tointubate under emergency conditions. Similarly there is tremendousamount of fat in the neck that makes emergency tracheotomies extremelyhazardous.

Prior to current conservative measures, post operative deaths were notuncommon in severe OSAS patients. Moreover these patients often haveacclimated to breathing against resistance, and when the resistance issuddenly removed their respiratory drive decreases. Even today thestandard of care in treating most OSAS patients is to have them underclose observation in an intensive care unit or recovery room aftersurgical procedures.

Soft Palate Procedures for Snoring

As the soft palate vibrates more than other tissues it plays adisproportional role in snoring. Various surgical therapies areavailable that shrink or stiffen the soft palate. The main procedureused is called uvulopalatopharyngoplasty (UPPP). UPPP excises excesssoft tissue of the pharyngeal walls and soft palate with a surgicalscalpel. Because so much mucosa of the pharyngeal area is traumatizedduring a UPPP there is a large amount of post operative swelling andsevere pain. In selected patients who snore but have no obstructionsmore limited versions of the UPPP can be done with lasers or electricalcautery.

Newer procedures minimize trauma to the mucosa and use needles to reachthe underlying soft tissue to shrink its volume or stiffen it so that itresists vibration. Electrodes can be inserted into the soft palate todeliver radiofrequency energy that shrinks or stiffens the palate(Powell, N B, et al (1998) Radiofrequency volumetric tissue reduction ofthe palate in subjects with sleep-disordered breathing. Chest 113,1163-1174.) (Somnoplasty; Somnus; Mountainview, Calif.). Mild causticagents can be injected that decrease the volume of the soft palate. U.S.Pat. No. 6,439,238 to Benzel teaches the application of a stiffeningagent to the surface of the soft palate. Most recently, office basedimplantation of plastic inserts to stiffen the soft palate has beenapproved by the FDA (Pillar® Procedure, U.S. Pat. No. 6,546,936: Methodand apparatus to treat conditions of the naso-pharyngeal area).

The fundamental shortcoming of all procedures that target the softpalate, including the newer techniques, is that they only partiallyimprove OSAS (Loube D I (1999) Technologic Advances in the Treatment ofObstructive Sleep Apnea Syndrome. Chest. 1999; 116:1426-1433, Doghramji,K, et al (1995) Predictors of outcome for uvulopalatopharyngoplasty.Laryngoscope 105, 311-314). Although studies report a decrease in thenumber of apneas these patients are rarely cured. Evidently the criticalstructure causing OSAS is not the soft palate but the tongue.

Tongue Base Procedures for OSAS

The methods used to treat the tongue base in OSAS are either topermanently decrease its volume, to decrease its flexibility or to movethe entire tongue forward.

Surgical excision of the tongue base has been poorly effective. Theresults for scalpel or laser resection of the tongue base in OSAStreatment have not been good enough to recommend continued applicationof these procedures (Mickelson, S A, Rosenthal, L (1997). Midlineglossectomy and epiglottidectomy for obstructive sleep apnea syndrome.Laryngoscope 107, 614-619).

More recently radiofrequency (U.S. Pat. No. 5,843,021 to Edwards) andultrasonic (U.S. Pat. No. 6,409,720) energy have been proposed to shrinkand stiffen the tongue base with radiofrequency energy. Theradiofrequency energy is delivered via needle electrodes that areinserted into the tongue base to cause a lesion that scars and shrinksover time. To avoid postoperative swelling and pain a limited amount oflesioning is done in a single session and patients require an average of5 treatments. About a third of patients have greater than 50%improvement in their OSAS. However, approximately a fourth of patientshave significant post operative complications, including, tongue baseulceration and abscesses, and temporary tracheotomy.

A recent introduced device for tongue base advancement is the Repose®system (Influent Corp; San Francisco, Calif.). The Repose® procedure isperformed under general anesthesia, and a screw is inserted at the baseof the mandible. The screw contains attachments for a permanent suturethat is tunneled under the mucosa of the floor of the mouth to the backof the tongue, then passed across the width of the tongue base, andbrought back to attach to a metal hook screwed into the bone of themandible. The suture is tightened to displace the tongue base forward,and caution must be observed to prevent excess tension leading tonecrosis of tissue. Unfortunately studies of the Repose® procedure showthat it is ineffective at eliminating OSAS. Only 1 of 15 patients wascured of OSAS while 2 patients had to have the suture removed due topain and swelling.

More aggressive surgical procedures require reconstruction of themandible, facial, skeleton or the hyoid bone. An example of the art isU.S. Pat. No. 6,161,541 to Woodson that teaches a method of surgicallyexpanding the pharyngeal airway. These procedures require extensivesurgery with higher risks and much longer recovery periods.

Other proposed methods for treating the tongue base include stiffeningthe soft tissue by injection of sclerosing particles U.S. Pat. No.6,742,524 or other implanted material U.S. Patent ApplicationPublication No. 20050004417A1.

Neuroprosthetic Devices

Various neuroprosthetic devices have been invented that stimulate upperairway muscles. U.S. Pat. No. 4,907,602 to Sanders describestransmucosal stimulation to dilate the airway; U.S. Pat. No. 5,792,067to Karell teaches an intraoral device that applies electricalstimulation to the hard palate, soft palate or pharyngeal area to inducecontraction of the upper airway muscles; U.S. Pat. No. 5,190,053 to Meerteaches an intraoral device that applies electrical stimulation to thegenioglossus muscle via electrodes located on the mucosa on the floor ofthe mouth on either side of the frenulum. In addition U.S. Pat. No.5,591,216 to Testerman describes a totally implantable device tostimulate the nerves to the genioglossus muscles. In addition, WIPOPublication No. 04064729 to Gordon describes a neuroprosthetic devicethat can be injected into the soft palate to treat snoring. At presentthese devices have not been clinically proven.

In summary, sleep disorders are a significant health problem without anacceptable solution and there is a need in the art for new and moreeffective therapies.

While not wishing to be bound by theory my studies of human tongueanatomy suggest that episodes of obstruction evolve by a sequence ofevents (FIGS. 4A-4G). The initial inciting event is the deformation of arelatively small part of the tongue. Under certain conditionsdeformation begins in soft tissue on the top of the tongue, particularlyin the area of the tongue curve, and specifically near the center lineof the tongue curve. As this tissue deforms it narrows the airway andcauses more negative pressure thereby causing greater deformation. Thisfeedback cycle in turn deforms enough tissue in the area to cause acomplete obstruction in the velopharyngeal area.

If an initial obstruction occurs near the end of inspiration, theobstruction is relieved by an expiration, or by action of thegenioglossus muscle. However, if the obstruction occurs at the beginningof inspiration reflexes trigger stronger inspiratory effort that furtherlowers airway pressure. This increased negative pressure causesdeformation and collapse of most of the tongue base. At this point theairway is firmly plugged by soft tissue and activity of the genioglossusonly stretches the tongue tissue that is plugged and cannot dislodge it.

Therefore the tongue curve is the critical area that initiates thecascade leading to obstruction. This relaxed muscle is very flexible andeasy to deform, however, the converse is also true, very little force isneeded to prevent this deformation. Therefore if sufficient counterforceis exerted at the proper localized area of the tongue it can preventobstruction without noticeable effects on speech and swallowingmovements.

How a device could prevent the deformation and collapse of the tonguecurve is not a trivial problem:

-   -   This area of the tongue is very mobile during speech and        swallowing, therefore the amount of force exerted must be low        and highly localized. It is unacceptable to render the area        immobile, as would be done if were stiffened by a large implant        or scar tissue,    -   The whole area of the velopharynx has extensive sensory        innervation, and relatively minor stimulation there causes        either a gag or a swallow.    -   The tongue base and body have a larger blood supply than        comparable muscles elsewhere in the body. Any implant placed in        the area has a high probability of causing internal bleeding        with potentially catastrophic tongue swelling.    -   Soft tissue and tongue in particular remodel easily.        Specifically sutures or implants that exert force cause the        tissue to remodel to relieve that force. This is known as the        cheese cutter effect. Therefore the forces applied must be        relatively low and applied for limited periods.    -   Humans' upper airway anatomy is highly variable, and the        pathological anatomy of sleep apnea patients is even more        variable. Moreover the upper airway anatomy of sleep apnea        patients changes over time as the disease progresses or        improves.    -   Finally, OSAS patients have borderline airways that can obstruct        after even minor amounts of swelling such as that following        surgical manipulation. Therefore it is not obvious how a device        could both exert force in the area yet avoid swelling.

Moreover to be maximally effective and get patient and physicianacceptance the device would ideally require additional qualities:

-   -   It should be capable of being inserted as an outpatient        procedure.    -   Preferably the device could he removed during the day and        reinserted by the patient at night.    -   It would be adjustable to conform to the specific needs of the        patient.    -   It would be comfortable for the patient.    -   When the device was in place it would not be noticeable to        anyone else.

SUMMARY OF THE INVENTION

There is a tremendous variability in human upper airway anatomy, andeven further variation in the pathological changes contributing to sleepapnea and related disorders. Moreover, the pathological anatomy changesover time in each patient as their condition improves or deteriorates.No single method and device is able to treat all contingencies.Therefore there is a critical need for methods and devices that areoptimized for different sites in the upper airway.

Embodiments of the invention include methods and devices to prevent ortreat upper airway disorders in mammals related to impaired airflow.These disorders are, without limitation, snoring, upper airwayresistance syndrome, and obstructive sleep apnea. In addition, thisinvention is applicable to airway disorders in animals including but notlimited to dorsal displacement of the soft palate in horses andbrachycephlic obstructive airway syndrome in certain breeds of dog.Those skilled in the art will readily appreciate that application ofthis invention can be applied to other conditions of the upper airway.

One aspect of the invention prevents airway obstruction by dilating theairway or preventing the tissue from deforming. It enlarges the airwaywhen excess tissue is present and also counteracts the deforminginfluence of negative airway pressure on the relaxed soft tissue ofupper airway structures. These structures include, without limitation,the tongue, soft palate, pharyngeal walls and supraglottic larynx.

PCT Publication No. WO 2005/082452 describes one embodiment of themethod and device herein referred to as a Linguaflex tongue retractor(LTR), notwithstanding that the use of the device as disclosed herein isnot limited to the tongue or to retraction. The LTR consists of aretractor (R), a shaft (S), and an anchor (A). In a preferred embodimenta retractor is physically coupled to the soft tissue of the tongue base.The shaft passes through the midline of the tongue to connect with ananchor. The anchor imparts counterforce through the shaft to theretractor, thereby preventing deformation of the soft tissue.

One aspect of this invention describes improvements to the retractorhead, shaft and anchor that increase the efficacy of the device whiledecreasing patient discomfort. Improvements of the LTR componentsinclude but are not limited to a retractor head that collapses to fitwithin a narrow delivery device and expands after insertion; a shaftthat passively adjusts its length and tension in response to surroundingtongue activity; and a modified anchor that is adjustable by the patientand attaches to a soft bolster, a partially implanted receptacle in themouth, and/or a dental appliance.

One aspect of the invention is a method of making the implant morecomfortable by allowing the device to be under little or no tensionduring the day, the unloaded state, and to increase the tension totherapeutic levels at night, the loaded state. This method increases thecomfort for the patient and allows the patient a large degree ofcontrol. The method and the devices that implement the method are ofgreat importance as the lack of patient compliance is perhaps thelargest problem with current sleep apnea therapies.

Another aspect of this invention is that additional sites in and aroundthe tongue can unexpectedly be treated with this invention to preventairway disorders. Non-limiting examples of these sites are the base oftongue, the mucosa covering the tongue, the tongue frenulum, thepharyngoglossal, palatoglossal and aryepiglottic folds, the lateralpharyngeal wall and soft palate. An improved LTR applied to these sitesdirectly or indirectly stiffens and displaces the tongue base, softpalate and lateral pharyngeal walls and enlarges the velopharynx. Eachsite has specific anatomy for which novel and unexpected improvements tothe LTR allow it to perform efficiently with minimal risk and discomfortto the patient.

One aspect of this invention is an LTR that indirectly retracts tonguebase by its implant site in the frenulum area. This simplifies theinsertion, adjustment and maintenance of the device.

Another aspect of this invention describes a highly localized and fullyimplantable LTR that is inserted into the base of the tongue to stiffenlax surface mucosa or mechanically couple it to internal tonguestructures.

Another aspect of this invention is an LTR inserted in or around thepharyngoglossal fold. This site allows retraction and stiffening oftongue base tissue as well as the soft palate and lateral pharyngealwall. The advantage of this site is its minimal invasiveness, safety andits beneficial effect on multiple different structures.

Another aspect of this invention is a method and device to remodel upperairway tissue in order to enlarge the pharyngeal airspace. Tissuesremodeled include but are not limited to tongue base, palatine tonsil,pharyngeal wall and soft palate. Preferably these tissues are eithercompressed to decrease their volume, or displaced or reshaped. Thiseffect lasts months to years after the devices have been removed. Toachieve this persistent beneficial effect, devices would preferablyexert force preferably from 1 week to 1 year, more preferably for 1 to 6months.

Another aspect of this invention are non-invasive methods and devicesthat reversibly couple to mucosa to grasp, move and/or reposition softtissue using magnets, adhesives, vacuum, and/or mechanical leverage. Inone embodiment a curved retractor member is reversibly inserted intoselected sites. In another embodiment indwelling clips are placed on thePGF, tonsillar folds, soft palate and other soft tissue folds. Theseretractor members can be loaded as needed by coupling them to modifiedanchors in or outside the mouth. In still another embodiment the floorof mouth is protracted to displace the tongue base. In a still furtherembodiment a vacuum reshapes the tongue to decrease base of tonguevolume.

Another aspect of this invention describes LTRs specifically adapted toprevent dorsal displacement of the soft palate in horses.

In each site the LTR has multiple embodiments. The LTR can pass throughtissue and have its retractor or anchor ends outside of tissue, or haveonly one end exposed, or the entire device can be implanted. The shaftof the device can pass deeply into the tissue, or pass superficiallyjust beneath the mucosa. The retractor and anchor member is preferablyshaped to fit its site so as to distribute force evenly: flat for flator mildly curved surfaces such as the mid tongue base, pharyngeal wall,and soft palate; wedge shaped for the depths of the pharyngoglossal foldand lateral margin of the soft palate; V shaped for the frenulum; and Tshaped for the teeth. The materials of the implant, retractor and anchorcould be of any of the well known non-reactive biocompatible materialsknown in the art. Non-limiting examples of rigid materials includestainless steel, titanium, ceramics, and plastics. Elastomeric materialsinclude silicon and rubber. The force needed to displace the tongueanteriorly or the soft palate superiorly varies from 0.001 gram to10,000 grams. More preferable 0.1 gram to 1000 grams, most preferably10-100 grams. This force could be applied from 0.01 sec to permanently.More preferable one minute to 1 month. Even more preferably for theduration of sleep. Most preferably during episodes of restricted upperairway flow.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be more readily understood from the detaileddescription of exemplary embodiments presented below considered inconjunction with the attached drawings, of which:

FIG. 1 is a side cross-sectional view of the human upper airway in themid saggital plane;

FIG. 2 is a simplified schematic side cross-sectional view of the tongueand surrounding structures;

FIG. 3 is a side cross-sectional view showing anatomical landmarks ofthe tongue;

FIG. 4A shows a side cross-sectional view of the tongue of a patientthat is awake;

FIG. 4B shows a side cross-sectional view of the tongue of a patientwith apnea;

FIG. 4C shows a side cross-sectional view of the tongue of a patientwith apnea after the airway has been obstructed;

FIG. 4D shows a side cross-sectional view of the tongue of a patientusing a CPAP device for treating sleep apnea;

FIG. 4E shows a side cross-sectional view of the tongue of a patientusing a prior art dental device for treating sleep apnea;

FIG. 4F shows a side cross-sectional view of the tongue of a patientusing an embodiment of the inventive tissue retractor;

FIG. 5A shows a side view of an embodiment of the inventive tissueretractor;

FIG. 5B shows a side cross-sectional view of the tissue retractor shownin FIG. 5A implanted in the tongue;

FIG. 5C shows a back view of the tongue curve with the tissue retractorshown in FIG. 5A implanted in the tongue;

FIG. 5D shows a back view of the tongue base with the tissue retractorshown in FIG. 5A implanted in the tongue;

FIG. 6A shows a front view of one embodiment of a retractor of theinventive tissue retractor;

FIGS. 6B and 6C show a side view of the retractor shown in FIG. 6A;

FIG. 6D shows a front view of the retractor shown in FIG. 6A;

FIG. 6E shows a side view of an inventive tissue retractor having theretractor shown in FIGS. 6A-6D mounted within a needle;

FIG. 6F shows a side view of the needle shown in FIG. 6E passing throughtissue;

FIG. 6G shows a side view of the needle shown in FIGS. 6E and 6F afterthe needle has passed through the tissue;

FIG. 6H shows a side view of the position of the retractor shown in FIG.6A after the inventive tissue retractor has been implanted in thetissue;

FIG. 7A shows a cross-sectional view of an embodiment of the inventivetissue retractor implanted in the tongue when the patient is awake;

FIG. 7B shows a cross-sectional view of the tissue retractor shown inFIG. 7B implanted in the tongue when the patient is asleep;

FIG. 7C is a cross-sectional view of the tissue retractor shown in FIG.7A implanted in the tongue when the patient is swallowing or speaking;

FIG. 8A shows a front view of an embodiment of a bolster of oneembodiment of the inventive tissue retractor;

FIG. 8B shows a top view of the bolster of FIG. 8A;

FIG. 8C shows a side view of the bolster of FIG. 8A;

FIG. 8D shows a side cross-sectional view of the inventive tissueretractor implanted in the tongue without the bolster shown in FIG. 8A;

FIG. 8E shows a side cross-sectional view of the inventive tissueretractor implanted in the tongue with the bolster shown in FIG. 8Abeing placed under the tongue;

FIG. 8F shows a side cross-sectional view of the inventive tissueretractor implanted in the tongue with the bolster shown in FIG. 8A inposition under the tongue;

FIG. 8G shows a front view of the anchor of the inventive tissueretractor engaging the bolster shown in FIG. 8A;

FIG. 8H shows a top view of the inventive tissue retractor implanted inthe tongue with the bolster shown in FIG. 8A in position under thetongue;

FIG. 9A shows a top view of one embodiment of the inventive tissueretractor;

FIG. 9B shows a top view of the tongue and the mandible with theinventive tissue retractor shown in FIG. 9A implanted from the tonguebase to the frenulum and interacting with the front teeth;

FIG. 9C shows a top view of another embodiment of the inventive tissueretractor;

FIG. 9D shows a top view of the tongue and the mandible with theinventive tissue retractor shown in FIG. 9C implanted through thepharyngoglossal fold (PGF) and interacting with the back teeth;

FIG. 9E shows a side cross-sectional view of another embodiment of theinventive tissue retractor and possible coupling extension to the softpalate, PGF, floor of mouth, and tongue surface;

FIG. 10A shows a side cross-section of the tongue and mandible cut inthe centerline (mid-sagittal plane);

FIG. 10B shows a side cross-sectional schematic of the tongue andmandible cut in the centerline (mid-sagittal plane);

FIG. 10C shows a side cross-sectional schematic of the frenulum area;

FIG. 11A shows a side cross-section of the tongue and mandible cut inthe centerline (mid-sagittal plane);

FIG. 11B shows a side cross-sectional schematic of the tongue andmandible cut in the centerline (mid-sagittal plane);

FIG. 11C shows a side cross-sectional schematic of the tongue andmandible cut in the centerline (mid-sagittal plane) with an embodimentof the inventive tissue retractor passing through the frenulum area andanchored externally to a dental anchor;

FIG. 11D shows a side cross-sectional schematic of the tongue andmandible cut in the centerline (mid-sagittal plane) with an embodimentof the inventive tissue retractor passing through the boundary layer andanchored to a frenulum anchor;

FIG. 11E shows a side cross-sectional schematic of the tongue andmandible cut in the centerline (mid-sagittal plane) with an embodimentof the inventive tissue retractor fully implanted in the frenulum areaconnecting the boundary area in two places;

FIG. 12A shows a front section of the tongue base;

FIG. 12B shows a front section schematic of the tongue base of FIG. 12A;

FIG. 12C shows a front section schematic of the tongue base with anembodiment of the inventive tissue retractor implanted in the softtissue;

FIG. 12D shows the tongue as seen in the mid-sagittal plane;

FIG. 12E shows a schematic drawing of the tongue as seen in themid-sagittal plane of FIG. 12D;

FIG. 12E shows a schematic drawing of the tongue as seen in themid-sagittal plane of FIG. 12D with the position in which the inventivetissue retractor would be placed being shown;

FIG. 13A shows a side cross-sectional view of the tongue with anembodiment of the inventive tissue retractor implanted in a firstposition;

FIG. 13B shows a top view of the tongue of FIG. 13A;

FIG. 13C shows a side cross-sectional view of the tongue with anembodiment of the inventive tissue retractor implanted in a secondposition;

FIG. 13D shows a top view of the tongue of FIG. 13C;

FIG. 13E shows a side cross-sectional view of the tongue with anembodiment of the inventive tissue retractor implanted in a thirdposition;

FIG. 13F shows a top view of the tongue of FIG. 13E;

FIG. 13G shows a side cross-sectional view of the tongue with anembodiment of the inventive tissue retractor implanted in a thirdposition;

FIG. 13H shows a top view of the tongue of FIG. 13G;

FIG. 13I shows a side cross-sectional view of an embodiment of apartially implantable anchor member for an embodiment of the inventivetissue retractor;

FIG. 13J shows a top view of the partially implantable anchor member ofFIG. 13I;

FIG. 13K shows a side cross-sectional view of the partially implantableanchor member shown in FIG. 13I engaged with the shaft of the inventivetissue retractor;

FIG. 13L shows a side cross-sectional view of the partially implantableanchor member shown in FIG. 13I with the extension of the anchor memberdepressed flush with the mucosa when not in use;

FIG. 13M shows a side cross-sectional view of the tongue with anembodiment of the inventive tissue retractor having an elastic sleeveimplanted in a first position;

FIG. 13N shows a top view of the tongue of FIG. 13M;

FIG. 13O shows a side cross-sectional view of the tongue with anembodiment of the inventive tissue retractor having a shaft passingacross the tongue base and connecting to a semi-implanted retractormember;

FIG. 13P shows a top view of the tongue of FIG. 13O;

FIG. 13Q shows a side cross-sectional view of the tongue with anembodiment of the inventive tissue retractor having a shaft passingthrough the tongue blade to an intermediate anchor on the superiorsurface of the tongue;

FIG. 13R shows a top view of the tongue of FIG. 13Q;

FIG. 13S shows a side cross-sectional view of the tongue with anembodiment of the inventive tissue retractor having a rigid shaftconnecting an anchor member below the tongue blade to a retractor memberabove the tongue blade;

FIG. 13T shows a side cross-sectional view of the tongue shown in FIG.13S with the retractor member rotated forward by a sleeve that isreversibly placed over the tongue blade;

FIG. 14A shows a side cross-sectional view of the upper airway;

FIG. 14B shows a side view of tongue in relation to mandible with thearea of superior PGF attachment marked;

FIG. 14C shows the palatoglossus muscle connecting the soft palate tothe superior PGF;

FIG. 14D shows the superior pharyngeal constrictor muscle connecting thepharyngeal walls to the superior PGF;

FIG. 14E shows the retraction force of the PGF being dispersed to thetongue base, soft palate, and lateral pharyngeal walls;

FIG. 15A shows a side cross-sectional view of the posterior collapse ofthe tongue and its effect on the airway;

FIG. 15B shows a side cross-sectional view of one embodiment of theinventive tissue retractor implanted with a retractor at the PGF and ashaft that passes across the frenulum to a retractor in the other PGF;

FIG. 15C shows a side cross-sectional view of one embodiment of theinventive tissue retractor implanted with a retractor in the PGF and ashaft passing through tongue tissue to emerge and connect to a modifiedanchor and an alternative embodiment passing through the floor of mouthto an external anchor resting on the skin;

FIG. 15D shows a side cross-sectional view of one embodiment of theinventive tissue retractor implanted with a retractor in or near the PGFand a shaft passing through the tongue to an anchor implanted ingenioglossus muscle or a floor of mouth structure;

FIG. 15E shows a side cross-sectional view of one embodiment of theinventive tissue retractor implanted with a retractor in the superiorPGF and an anchor in the inferior PGF;

FIG. 15F shows a side cross-sectional view of one embodiment of theinventive tissue retractor implanted with a retractor in the PGF and ashaft passing through the tongue to an anchor on the superior surface ofthe tongue;

FIG. 16A shows a side cross-sectional view of one embodiment of theinventive tissue retractor implanted with a retractor at the tongue baseconnected by two sub-mucosal shafts to anchors in front of each PGF;

FIG. 16B is a top view of FIG. 16A;

FIG. 16C shows a side cross-sectional view of one embodiment of theinventive tissue retractor implanted with a sub-mucosal shaft connectedto two retractor/anchor members in front of each PGF;

FIG. 16D is a top view of FIG. 16C;

FIG. 16E shows a side cross-sectional view of one embodiment of theinventive tissue retractor implanted with two implanted retractor/anchormembers in or near the PGFs connected by a sub-mucosal shaft;

FIG. 16F is a top view of FIG. 16E;

FIG. 16G shows a side cross-sectional view of one embodiment of theinventive tissue retractor implanted with magnets in or near each PGFand connected by a sub-mucosal shaft;

FIG. 16H is a top view of FIG. 16G;

FIG. 161 is a front and a side view of a magnet of one embodiment of theinventive tissue retractor implanted in a PGF;

FIG. 16J is a front and a side view of a magnet of one embodiment of theinventive tissue retractor implanted in a PGF where the magnet isenclosed in an implant that has two flanges to keep it in place withinthe PGF;

FIG. 16K shows a top view of another embodiment of the inventive tissueretractor having a hook;

FIG. 16L shows a top view of the tongue and the mandible showing theinventive tissue retractor shown in FIG. 16K and an alternativeembodiment of the inventive tissue retractor using magnets;

FIG. 17A shows a front view of the mouth showing the soft palate (SP),the palatopharyngeus fold (PAPHF) and palatoglossal folds (PAF) withvarious placements of embodiments of the inventive tissue retractor;

FIG. 17B shows FIG. 17A with mucosa removed to show the underlyingmuscles (right side) and the nerve and blood supply (left side) withvarious placements of embodiments of the inventive tissue retractor;

FIG. 17C shows a view of the left lateral pharyngeal wall area aftermid-sagittal section with the tongue retracted inferiorly with variousplacements of embodiments of the inventive tissue retractor;

FIG. 18A shows a view of the left lateral pharyngeal wall area aftermid-sagittal section with the tongue retracted inferiorly with anembodiment of the inventive tissue retractor implanted with theretractor on the posterior surface of posterior tonsillar fold and theanchor on the anterior surface of anterior tonsillar fold;

FIG. 18B shows a view of the left lateral pharyngeal wall area aftermid-sagittal section with the tongue retracted inferiorly with anembodiment of the inventive tissue retractor implanted with theretractor superior to the palatoglossus fold and the anchor inferiorpalatoglossus fold;

FIG. 18C shows a view of the left lateral pharyngeal wall area aftermid-sagittal section with the tongue retracted inferiorly with anembodiment of the inventive tissue retractor implanted withinpalatoglossus muscle;

FIG. 18D shows a view of the left lateral pharyngeal wall area aftermid-sagittal section with the tongue retracted inferiorly with anembodiment of the inventive tissue retractor implanted with the anchorat lateral aspect of soft palate and the retractor at the midline;

FIG. 18E shows a view of the left lateral pharyngeal wall area aftermid-sagittal section with the tongue retracted inferiorly with anembodiment of the inventive tissue retractor implanted with theretractor on an inner surface of palatoglossal fold and a modifieddental anchor;

FIG. 18F shows a view of the left lateral pharyngeal wall area aftermid-sagittal section with the tongue retracted inferiorly with anembodiment of the inventive tissue retractor implanted with theretractor at the posterior tonsillar fold and the anchor at the anteriortonsillar fold;

FIG. 19A is a top view of an embodiment of the inventive tissueretractor implanted with the anchor at the superior pharyngeal side ofthe soft palate and the retractor at the inferior oral side of the softpalate;

FIG. 19B is a side view of the embodiment shown in FIG. 19A;

FIG. 19C is a top view of an embodiment of the inventive tissueretractor implanted with the retractor at the superior oral side of thesoft palate and the retractor at the inferior pharyngeal side of thesoft palate;

FIG. 19D is a side view of the embodiment shown in FIG. 19C;

FIG. 19E is a top view of an embodiment of the inventive tissueretractor implanted with the anchor at the superior pharyngeal side ofthe soft palate, the retractor at the inferior oral side of the softpalate, and an added bolster engaging the anchor;

FIG. 19F is a side view of the embodiment shown in FIG. 19E;

FIG. 19G is a top view of an embodiment of the inventive tissueretractor fully implanted in the soft palate;

FIG. 19H is a side view of the embodiment shown in FIG. 19G;

FIG. 19I is a top view of an embodiment of the inventive tissueretractor implanted through the soft palate with the anchor opposite theretractor;

FIG. 19J is a side view of the embodiment shown in FIG. 19I;

FIG. 19K is a top view of the embodiment of the inventive tissueretractor shown in FIG. 19I and including retainers that lift edge ofsoft palate;

FIG. 19L is a side view of the embodiment shown in FIG. 19K;

FIG. 20A shows a side cross-sectional view of a horse's airway duringexercise;

FIG. 20B shows a side cross-sectional view of dorsal displacement of thesoft palate of a horse;

FIG. 20C shows a side cross-sectional view of an embodiment of theinventive tissue retractor implanted through the mandible of the horseto an adjustable anchor in front of the mandible;

FIG. 20D shows a side cross-sectional view of an embodiment of theinventive tissue retractor implanted in a horse with the shaftconnecting to an anchor on the tongue surface of the horse which isreversibly attached to the bit of a bridle during exercise;

FIG. 20E shows a side cross-sectional view of an embodiment of theinventive tissue retractor implanted in a horse with an anchor in frontof the soft palate of the horse and a shaft passing backward and thenthrough the epiglottis to a retractor on the laryngeal surface of theepiglottis;

FIG. 20F shows a side cross-sectional view of an embodiment of theinventive tissue retractor implanted in a horse with the shaft passingfrom the PGFs to the lateral aspect of the soft palate;

FIG. 20G shows a front view of the tongue of the horse with theembodiments of the inventive tissue retractors shown in FIGS. 20E and20F;

FIG. 21A shows a side view of airway obstruction due to backwardcollapse of the tongue;

FIG. 21B shows a side view of a non-invasive embodiment of the inventivetissue retractor with a soft “hook” retracting the PGF forward andthereby retracting the base of tongue, soft palate and pharyngeal walls;

FIG. 21C shows a side view the soft “hook” shown in FIG. 21B;

FIG. 21D shows a side view of a non-invasive embodiment of the inventivetissue retractor with a clip compressing the soft tissue;

FIG. 21E shows a side view of a non-invasive embodiment of the inventivetissue retractor with a clip where compression of the soft tissue isprovided by opposing magnets;

FIG. 21F shows a side view of the non-invasive embodiment of theinventive tissue retractor shown in FIG. 21E where the magnets arecoupled to a modified anchor;

FIG. 21G shows a top view of a non-invasive embodiment of the inventivetissue retractor with having two hook retractors;

FIG. 21H shows a top view of the hook of the non-invasive embodiment ofthe inventive tissue retractor shown in FIG. 21G;

FIG. 22A shows a side view of a non-invasive embodiment of the inventivetissue retractor in the form of a clip placed on a soft tissue fold;

FIG. 22B shows a top view of the non-invasive embodiment of theinventive tissue retractor shown in FIG. 22A;

FIG. 22C shows a front view of the non-invasive embodiment of theinventive tissue retractor shown in FIG. 22A;

FIG. 22D shows a front view of a non-invasive embodiment of theinventive tissue retractor having two clips;

FIG. 22E shows a view of the left lateral pharyngeal wall area aftermid-sagittal section with the tongue retracted inferiorly with annon-invasive embodiment of the inventive tissue retractor with a clip onthe anterior tonsillar pillar attached to a dental anchor;

FIG. 22F shows a view of the left lateral pharyngeal wall area aftermid-sagittal section with the tongue retracted inferiorly with annon-invasive embodiment of the inventive tissue retractor with a clip onthe posterior tonsillar pillar attached to a dental anchor;

FIG. 22G shows a view of the left lateral pharyngeal wall area aftermid-sagittal section with the tongue retracted inferiorly with anon-invasive embodiment of the inventive tissue retractor with a clip onthe edge of soft palate attached to a dental anchor;

FIG. 22H shows a view of the left lateral pharyngeal wall area aftermid-sagittal section with the tongue retracted inferiorly with annon-invasive embodiment of the inventive tissue retractor with two clipsretracting the pharyngeal wall toward the aryepiglottic fold;

FIG. 23A is a side cross-sectional view of the mouth and upper airway;

FIG. 23B is a front view of the mouth and upper airway;

FIG. 23C is a top view of the mouth and upper airway;

FIG. 23D is a side cross-sectional view of an embodiment of theinventive tissue retractor with a bolster pushed downward and slightlyanterior by a protractor from a dental anchor (not shown);

FIG. 23E is a front view of the embodiment of the inventive tissueretractor shown in FIG. 23D;

FIG. 23F is a top view of the embodiment of the inventive tissueretractor shown in FIG. 23D;

FIG. 23G is a side cross-sectional view of an embodiment of theinventive tissue retractor comprising a bolster;

FIG. 23H is a front view of the embodiment of the inventive tissueretractor shown in FIG. 23G;

FIG. 23I is a top view of the embodiment of the inventive tissueretractor shown in FIG. 23G;

FIG. 23J is a side view of an inventive embodiment of a vacuum deviceapplied to the lateral tongue; and

FIG. 23K is a side view of the inventive embodiment shown in FIG. 23Kwith a vacuum applied to the lateral tongue.

It is to be understood that the attached drawings are for purposes ofillustrating the concepts of the invention.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1. Drawing of the human upper airway in the mid saggital plane.

NC, Nasal Cavity

SP, Soft Palate

PH, Pharynx

ES, Esophagus

P, Hard Palate

MD, Mandible

T, Tongue

LR, Larynx

TR, Trachea

FIG. 2. Simplified schematic drawing of the tongue and surroundingstructures

NP, Nasopharynx

VP, Velopharynx

HP, Hypopharynx

SP, Soft palate

P, Hard palate

T, Tongue

GG, Genioglossus muscle

OP, Oropharynx

RG, retroglossal space

Areas of the pharynx: Nasopharynx spans from the level of the hardpalate up. Velopharynx spans from the beginning of the end of the softpalate. Oropharynx spans from the edge of the soft palate to theepiglottis. Hypopharynx spans from the epiglottis to the esophagus. Thevelopharyngeal space (VP) is the area between the soft palate and backwall of the pharynx. The retroglossal space (RG) is the area between thetongue base and back wall of the pharynx.

FIG. 3. Anatomical landmarks of the tongue. The tongue will be definedas the grey area of this schematic. From front to back the tongue isdivided into a blade, body, and base. The genioglossus muscle (GG)inserts into a connective tissue boundary on the undersurface of thetongue (Bo). The entire region of the genioglossus muscle and its mucosais referred to as the “frenulum area”.

BA) Tongue base

BD) Tongue body

BL) Tongue blade

Bo) Boundary between tongue and genioglossus

C) Tongue curve

F) Frenulum

GG) Genioglossus muscle

FIGS. 4A-4F—Mechanism of airway obstruction and the effect of currenttherapies.

A) Normal tone in tongue while awake. Tongue remains in positionallowing airway to remain open. Blue arrow 410 shows airflow, smallblack arrow 412 shows the relationship of pharyngeal wall (red line 414)to mandible.

B) Apnea. During sleep muscle tone is lost in the tongue and it becomesflaccid. Negative pressure in the pharynx during inspiration causesbackward collapse of the tongue in the velopharyngeal area because theairway is narrowest at that point and the tongue curve (circle) is mostdeformable.

C) Apnea. After the airway obstructs at the velopharyngeal areainspiration lowers the pressure in the pharynx further causing the baseof tongue to deform and firmly block the airway.

D) CPAP works by pumping air at high pressure through the nose (thickblue line 416), thereby splinting the pharynx open.

E) Dental devices work by moving the entire jaw forward. As the tongueis attached to the soft tissues along the floor of the mouth, and theyattach to the jaw, the tongue is indirectly moved to expand the airway.Note that the jaw has moved in relation to the pharyngeal wall (arrow).

F) The LTR prevents posterior deformation of the tongue curve bydirectly restraining the tongue curve from moving backwards.

FIGS. 5A-5D—Embodiment of the LTR device. Shown is one embodiment of theLTR.

A. The LTR has three main components: a retractor (R), shaft (S), andanchor (A).

B. Side view of the LTR inserted in a tongue.

C. Back view of tongue curve showing retractor position.

D. Back view of tongue base showing the curved midline shape.

FIGS. 6A-6H—Retractor member. This figure illustrates a retractorcomponent of an LTR that can be mounted on a needle for implantationwithin upper airway tissue and deploys when the needle is withdrawn. Theretractor is shown as an integral component of the shaft and is moldedas one piece from soft elastomeric material.

A-D. Side and front views of the retractor head. The plane of theretractor rests at about 15° relative to the shaft.

E. Side view of retractor head mounted within a needle. A part of theretractor lays on the outer surface of the needle.

F. Side view of needle passing through tissue. Note that the retractorextension lays flat against the needle barrel and does not interferewith passage of the needle through tissue.

G. After the needle penetrates mucosa enough to clear the retractorextension it again extends away from the shaft.

H. Slight traction on the shaft causes the retractor to catch the mucosaand come to rest in its working position.

FIGS. 7A-7C—Shaft member. Shown is an improvement to the shaft of an LTRthat maintains its retractor tension when the tongue is relaxed, such asduring sleep. However, during speech and swallowing, when the tonguebase often moves backward, the activity of the tongue squeezes the shaftand thereby lengthens it. In this way there is little or no resistanceto the normal tongue movements.

A. Schematic view of LTR in the tongue with normal muscle tone. Notethat the retractor lays on the mucosal surface of the tongue basewithout indenting it.

B. During sleep the tongue loses all tone and tends to flop backwardinto the airway. The retractor then resists this deformation.

C. During swallowing and speech the tongue base sometimes movesbackward. During these movements there is a strong contraction of thetongue muscles. This contraction squeezes the upper shaft, this in turncauses the shaft to lengthen and move the retractor.

FIGS. 8A-8H—Anchor member, bolster

A. Front view of bolster.

B. Top view of bolster.

C. Side view of bolster.

D. Side view of tongue with unloaded LTR.

E. Anchor of shaft is pulled forward slotted into cleft on underside ofbolster.

F. Bolster in position under tongue.

G. Close up view of LTR anchor sitting in the recess of bolster.

H. Top view of tongue with LTR and bolster.

FIGS. 9A-9E—Anchor member, dental

A. A modified anchor that is implanted on the upper or lower frontteeth. The anchor (A) interfaces with the teeth, the shaft (S) connectsto retractor/coupler (R/C). The retractor/coupler either consists of aretractor that interfaces with tissue, or a coupler component thatconnects to an implanted retractor, shaft, or anchor member of animplanted LTR.

B. Drawing of top view of tongue and mandible with an LTR implanted fromthe tongue base to the frenulum. The anchor of the LTR can be reversiblyattached to the R/C component of the dental anchor.

C. Another embodiment of a modified anchor for use on the lateral teeth.

D. Top view of tongue and mandible with a lateral dental anchor. Theanchor attaches to the molar tooth, the shaft passes through thepharyngoglossal fold, and the retractor rests against the posteriorsurface of the fold.

E. Palatal prosthesis with some possible coupling extensions forretraction or protraction: the soft palate, PGF, floor of mouth andtongue surface.

FIGS. 10A-10C—Anchor member, frenulum area.

Within the genioglossus muscle are small tendons upon which musclefibers insert at various angles. The main tendon is in the middle of themuscle and smaller tendons branch off at various points. Preferably ananchor in the frenulum area (F) is inserted such that its implanted partpasses through a tendon (TD). However the anchor (A) can be inserted atany spot in the frenulum area or soft tissue attached to the mandible.The anchor could be coupled to an LTR by a variety of mechanisms asdescribed herein.

A. Side view of the tongue and mandible cut in the centerline(mid-sagittal plane).

B. Drawing of A.

C. Close up of the frenulum area.

FIGS. 11A-11E—Frenulum area embodiment.

A. Side view of tongue and mandible cut at the centerline. The frenulumis the front edge of the genioglossus muscle, frenulum area refers tothe entire genioglossus and surrounding mucosa. The front and rearboundaries of the genioglossus muscle are marked by solid lines. Thegenioglossus muscle attaches to a small area on the inner surface of themandible and tendinous extensions from that area. It fans out from theseattachments to insert mostly into connective tissue along the length ofthe body and base of the tongue called the boundary layer.

B. Drawing of A.

C. Shown is an LTR passing through the frenulum area and anchoredexternally to a dental anchor. The implanted part of the LTR exerts sideforces on the genioglossus muscle fascicles and this is conveyed to theboundary layer and finally to the tongue base (arrow).

D. Shown is an LTR passing through the boundary layer and anchored to afrenulum anchor. Displacement of the tongue is marked by the arrow.

E. Shown is a fully implanted LTR in the frenulum area connecting theboundary area in two places. Note that the beneficial retraction of thetongue base causes some retraction of the tongue blade, however, thisdoes not interfere with tongue function.

FIGS. 12A-12F—Tongue base implant.

A. Frontal section of tongue base.

B. Drawing of A. Light lines are the connective tissue of the tonguesuperior layer (SL) and midline septum (MS). ML, middle layer.

C. Position of LTR implant connecting SL and ML.

D. Tongue seen in mid-sagittal plane. Oval marks the area of mechanicaldecoupling.

E. Schematic drawing of the box marked in D.

F. Position of implant.

FIGS. 13A-13T Tongue base embodiments

A and B. Lateral (left) and top (right) drawings of the tongue with anLTR connected by a shaft passing underneath the tongue base mucosa.Green ovals 1310 correspond to anchors and retractors, shaft is dottedyellow when implanted and solid when outside, black arrows 1312 showdirection of traction.

C and D. An LTR with the shaft taking a more direct route betweenretractor and anchor.

E and F. An LTR with the shaft exiting from mucosa close to theretractor and anchor.

G and H. Implanted anchor and retractor with a reversible attachableshaft.

I. Lateral view of a partially implantable anchor or retractor.

J. Top view of a partially implantable anchor or retractor.

K. Partially implantable anchor/retractor showing the shaft connection.

L. Lateral view of a partially implantable anchor/retractor with theextension depressed flush with mucosa when not in use.

M and N. An LTR with an elastic sleeve placed over the tongue blade anda shaft connecting to a semi-implanted retractor member.

O and P. An LTR anchored at the PGFs and a shaft passing across thetongue base and connecting to a semi-implanted retractor member.

Q and R. An LTR anchored beneath the tongue blade with a shaft passingthrough the tongue blade to an intermediate anchor on the superiorsurface of the tongue. The shaft then passes posteriorly to asemi-implanted retractor member. This allows adjustment of tension fromthe anchor site beneath the tongue blade.

S and T. Left, a rigid shaft connects an anchor member below the tongueblade to a retractor member above the tongue blade. The retractor memberis rotated forward by a sleeve that is reversibly placed over the tongueblade. The rotation of the retractor member, along with the rigid shaft,displaces the tissue of the tongue base along the midline. Drawing isintentionally exaggerated to show the effects.

FIGS. 14A-14E—The Superior Palatoglossal Fold (SPGF).

A. Side view of the upper airway showing the area of the tongue (T)where the PGF inserts, i.e., the location of the pharyngolassal foldinsertion (PGFI). A smaller superior region is of particularsignificance as it receives overlapping insertions of muscles connectingto the soft palate (SP) and lateral pharyngeal walls (PHW), includingbut not limited to the palatoglossus (PA) and superior pharyngealconstrictor (SPHC) muscles.

B. Side view of tongue in relation to mandible with the area of superiorPGF attachment marked.

C. The palatoglossus muscle is shown connecting the soft palate to thesuperior PGF.

D. The superior pharyngeal constrictor muscle connects the pharyngealwalls to the superior PGF.

E. Schematic showing that retraction force of the PGF is dispersed tothe tongue base, soft palate, and lateral pharyngeal walls.

FIGS. 15A-15F—Pharyngoglossal Fold embodiments

A. Drawing showing the posterior collapse of the tongue and its effectson the airway.

B. A retractor at the PGF and a shaft that passes across the frenulum toa retractor in the other PGF.

C. A retractor in the PGF and a shaft passing through tongue tissue toemerge and connect to a modified anchor. An alternative embodimentpasses through the floor of mouth to an external anchor resting on theskin.

D. An implanted LTR with a retractor in or near the PGF and a shaftpassing through tongue to an anchor implanted in genioglossus muscle, orfloor of mouth structures.

E. An LTR with a retractor in the superior PGF and an anchor in theinferior PGF.

F. A retractor in the PGF and a shaft passing through tongue to ananchor on the superior surface of the tongue.

FIGS. 16A-16L—Pharyngoglossal Fold embodiments.

A and B. Retractor at tongue base connected by two sub-mucosal shafts toanchors in front of each PGF.

C and D. A sub-mucosal shaft connect two retractor/anchor members infront of each PGF.

E and F. Two implanted retractor/anchor members in or near the PGFs areconnected by a sub-mucosal shaft.

G and H. Magnets implanted in or near each PGF are connected by asub-mucosal shaft.

I. A magnet implanted in a PGF is retracted by a magnet of oppositepolarity attached to a modified anchor.

J. A magnet is enclosed in an implant that has two flanges to keep inplace within the PGF.

K. A schematic of a dental type modified anchor. The anchor member is aclasp that reversibly attaches to teeth as shown on right. A shaft ofvariable length attaches to a retractor member or a coupling mechanismthat in turn connects to an implanted LTR. The retractor member may be amagnet or mechanical mechanism.

L. Drawing of tongue and mandible seen from above. Two embodiments ofthe dental modified anchor are shown: bottom, the retractor member is amagnet that couples to an implanted magnet as shown in E left; top, theshaft ends with a magnet that couples to a reversible magnetic implantas shown in E, right.

FIGS. 17A-17C—Soft Palate embodiments.

A. View of the mouth showing the soft palate (SP), the palatopharyngeusfold (PAPHF) and palatoglossal folds (PAF) (Henry Gray. Anatomy of theHuman Body. 1918).

B. Same view as A but with mucosa removed showing the underlying muscles(right side) and the nerve and blood supply (left side).

C. View of the left lateral pharyngeal wall area after mid-sagittalsection. Tongue is retracted inferiorly.

Four preferred LTR placements are shown with an anchor in the superiorPGF: 1) Shaft passes next to palatoglossus muscle (PAM) around tonsil(TN), retractor rests against lateral edge of soft palate. Preferredembodiment for increasing lateral velopharyngeal area. 2) Shaft travelswithin palatoglossus muscle, retractor near midline soft palate.Preferred embodiment for increasing medial velopharyngeal airspace; 3)Shaft passes through palatoglossus muscle, palatine tonsil, andpalatopharyngeus muscle (PAPHM), retractor rests against posterior wallof soft palate. Preferred embodiment for compression and permanentremodeling of palatine tonsil. 4) Shaft passes 1 cm under tongue basemucosa, retractor rests against tongue base. Preferred embodiment fortensing tongue base.

FIGS. 18A-18F—Tonsillar Fold embodiments

18A. Retractor posterior surface of posterior tonsillar fold, anchoranterior surface of anterior tonsillar fold. Preferred embodiment forcompression of palatine tonsil.

18B. Retractor superior Palatoglossus fold, retractor inferiorPalatoglossus Fold or PGF.

18C. Implanted LTR within palatoglossus muscle.

18D. Anchor at lateral aspect of soft palate, retractor midline.

18E. Retractor on inner surface of palatoglossal fold, modified dentalanchor.

18F. Retractor at posterior tonsillar fold and anchor at anteriortonsillar fold.

FIGS. 19A-19L—Soft palate embodiments

A and B. Anchor superior pharyngeal side, retractor inferior oral side.

C and D. Retractor superior oral side, anchor inferior pharyngeal side.

E and F. Bolster added in front of anchor to load the LTR. Noteindentation and rotation.

G and H. Totally implanted LTR.

I and J. Opposing retractor and anchor.

K and L. LTR as attachment for retainers that lift edge of soft palate.

FIGS. 20A-20G—Veterinarian embodiments

Shown are embodiments of this invention for equine dorsal displacementof the soft palate.

A. Normal configuration of the horse upper airway during exercise. Notethat the soft palate overlaps and interlocks the epiglottis of thelarynx to provide an open conduit for airflow (blue line 2010).

B. In DDSP the soft palate is dislodged from its locked position andobstructs the airway. This is believed to be caused by the backwardmovement of the tongue base.

C. An embodiment of an LTR for this condition. The shaft reaches throughthe mandible to an adjustable anchor in front of the mandible.

D. Another embodiment where the shaft connects to an anchor on thetongue surface which is reversibly attached to the bit of a bridleduring exercise.

E. An embodiment that directly opposes dislodging the soft palate fromits normal position. An anchor in front of the soft palate passesbackward and then through the epiglottis to a retractor on the laryngealsurface of the epiglottis.

F and G. In an alternative embodiment an LTR passes from the PGFs to thelateral aspect of the soft palate. View is from the front, tongue istransparent. For comparison the midline embodiment described in E isalso shown.

FIGS. 21A-21H—Non-invasive PGF retractor

A. Schematic of airway obstruction due to backward collapse of thetongue.

B. PGF retraction. Soft “hook” retract the PGF forward and therebyretracts the base of tongue, soft palate and pharyngeal walls.

C. Close up view of “hook”.

D. Close up view of “clip”. Clip remains in place by compressing softtissue by its arms.

E. An embodiment of the clip where compression is performed by magnets.

F. Embodiment from E where the magnets are also used to couple theretractor to a modified anchor.

G. Drawing of two hook retractors in place and their effect on thetongue base (dotted line).

H. Close-up view of hook LTR.

FIGS. 22A-22H Non-invasive retraction, clip embodiment.

A. Side view of clip on soft tissue fold. One method of adhering to thefold is to compress the tissue at the ends of the clip.

B. Side view of clip composed of opposing magnets of opposite polarity.Their magnet attraction provides sufficient force for a stable positionand a shaft is unnecessary.

C. Front view of clip on a soft tissue fold. The shaft connection canserve to retract the edge of the fold.

D. Clips used to provide protraction (lengthening, a useful effect onstructures that benefit from stiffening such as the soft palate andtongue base.

E. Clip on anterior tonsillar pillar attached to a dental anchor.

F. Clip on posterior tonsillar pillar attached to a dental anchor.

G. Clip on edge of soft palate attached to a dental anchor.

H. Two clips retracting the pharyngeal wall toward the aryepiglotticfold, thus stiffening the lateral pharyngeal wall.

FIGS. 23A-23K Non-invasive protraction and vacuum. Floor of mouthdepression.

A. Side view. Floor of mouth is marked by a checkered pattern thatextends from the mandible to the hyoid bone.

B. Front view. Floor of mouth connects to the bottom of each side of themandible.

C. Top view. Tongue is transparent and triangular root of tongue can beseen. The anterior extension of the root is the genioglossus muscleinsertion into the mandible.

D. Bolster pushed downward and slightly anterior by a protractor from adental anchor (not shown). Note the indentation of the FOM and thealtered position of the tongue and PGF.

E. FOM depression by bolster reflected by decreased height of tonguesurface.

F. Bolster seen from above. Note anterior displacement of base oftongue.

G. Bolster pushed anteriorly.

H. FOM depression by bolster.

I. Bolster seen from above. Note anterior displacement of base oftongue.

J. A vacuum device applied to the lateral tongue.

K. A vacuum device as a retractor member.

DETAILED DESCRIPTION

The term “subject” as used herein includes animals of mammalian origin,including humans. Anatomical terminology used to describe position andorientation as used herein can best be defined by the followingdescription:

When referring to animals that typically have one end with a head andmouth, with the opposite end often having the anus and tail, the headend is referred to as the cranial end, while the tail end is referred toas the caudal end. Within the head itself, rostral refers to thedirection toward the end of the nose, and caudal is used to refer to thetail direction. The surface or side of an animal's body that is normallyoriented upwards, away from the pull of gravity, is the dorsal side; theopposite side, typically the one closest to the ground when walking onall legs, swimming or flying, is the ventral side. On the limbs or otherappendages, a point closer to the main body is “proximal”; a pointfarther away is “distal”. Three basic reference planes are used inzoological anatomy. A “sagittal” plane divides the body into left andright portions. The “mid-sagittal” plane is in the midline, i.e. itwould pass through midline structures such as the spine, and all othersagittal planes are parallel to it. A “coronal” plane divides the bodyinto dorsal and ventral portions. A “transverse” plane divides the bodyinto cranial and caudal portions.

When referring to humans, the body and its parts are always describedusing the assumption that the body is standing upright. Portions of thebody which are closer to the head end are “superior” (corresponding tocranial in animals), while those farther away are “inferior”(corresponding to caudal in animals). Objects near the front of the bodyare referred to as “anterior” (corresponding to ventral in animals);those near the rear of the body are referred to as “posterior”(corresponding to dorsal in animals). A transverse, axial, or horizontalplane is an X-Y plane, parallel to the ground, which separates thesuperior/head from the inferior/feet. A coronal or frontal plane is anY-Z plane, perpendicular to the ground, which separates the anteriorfrom the posterior. A sagittal plane is an X-Z plane, perpendicular tothe ground and to the coronal plane, which separates left from right.The mid-sagittal plane is the specific sagittal plane that is exactly inthe middle of the body.

Structures near the midline are called medial and those near the sidesof animals are called lateral. Therefore, medial structures are closerto the mid-sagittal plane, lateral structures are further from themid-sagittal plane. Structures in the midline of the body are median.For example, the tip of a human subject's nose is in the median line.

Ipsilateral means on the same side, contralateral means on the otherside and bilateral means on both sides. Structures that are close to thecenter of the body are proximal or central, while ones more distant aredistal or peripheral. For example, the hands are at the distal end ofthe arms, while the shoulders are at the proximal ends.

Definitions

“Anchor” refers to a component of the device that mechanically couplesto a site that is immobile relative to the retractor.

“Deformation” refers to an abnormal change in the shape of upper airwaysoft tissue structures. This deformation can be due to negative pressureacting on relaxed upper airway structures during sleep causing them tonarrow the upper airway. Most preferably this soft tissue can be thetongue curve.

“Frenulum” refers to the vertical anterior edge of the genioglossusmuscle. The frenulum passes from the floor of the mouth up to thecenterline of the underside of the tongue. The frenulum marks theboundary between the tongue blade and tongue body.

“Frenulum area” refers to the genioglossus muscle and its surroundingmucosa.

“Loaded” refers to an LTR that can have its tension adjusted such thatit has minimal tension during the day and higher therapeutic levels oftension at night. The loaded configuration corresponds to the highertherapeutic levels.

“Modified anchor” is an additional component that allows attachment ofthe permanent anchor of the LTR. In some embodiments the modified anchorallows the patient to adjust tension in the LTR, specifically toincrease tension at night and release it during the day.

“Palate retractor” refers to a complete device used for the preventionsoft palate deformation.

“Permanent anchor” refers to an anchor component of an LTR that remainson the LTR for the duration of the implantation. The permanent anchorprevents the anterior end of the shaft from slipping back into tonguetissue. In certain embodiments the permanent anchor also serves as apart of a connector when a “modified anchor” is used.

“Pharyngeal wall retractor” refers to a complete device for theprevention of pharyngeal wall deformation.

“Protract” means to lengthen or push apart.

“Reverse deformation” refers to a change in soft tissue shape caused bythe tissue retractor. In some embodiments reverse deformation refers torestoring a deformed structure to its normal shape. In other embodimentsreverse deformation refers to an indentation of soft tissue in a givenarea due to the action of a tissue retractor.

“Sleep breathing disorders” refers to all breathing disorders occurringduring sleep including but not limited to obstructive sleep apnea,obstructive sleep apnea syndrome, upper airway resistance syndrome, andsnoring.

“Tongue base” refers to the part of the tongue posterior to the tonguecurve. In anatomical terms the line of demarcation of the tongue base isthe circumvallate papillae, a grossly visible line of raised tasteorgans on the superior surface of the tongue.

“Tongue blade” refers to the part of the tongue anterior to thefrenulum. It is covered by mucosa on its top, sides and undersurface.

“Tongue body” is the mid part of the tongue located between the tongueblade and tongue base.

“Tongue boundary” or “boundary” is the inferior surface of the tonguebody and base. The genioglossus muscle inserts onto a large part of theboundary.

“Tongue curve” refers to the area of the tongue where its superiorsurface curves from a horizontal orientation (tongue body and blade) toa vertical orientation (tongue base). Preferably tongue curve refers tothe soft tissue in this area between the mucosal covering of the tongueand the connective tissue boundary where the genioglossus muscleattaches.

“Tissue retractor” refers to the complete device of embodiments of theinvention for the prevention of soft tissue deformation. The device maybe used without limitation in the tongue, soft palate, or pharyngealwalls.

“Tongue retractor” refers to a complete device used for the preventionof tongue deformation. Preferentially it comprises a retractor connectedto a shaft which in turn is connected to an anchor.

“Laryngeal retractor” refers to a complete device for the prevention oflaryngeal soft tissue deformation.

“Retractor” or “retractor head” or “retractor member” refers to a partof the overall tissue retractor. The retractor physically interacts withsoft tissue, either directly or indirectly, to prevent it fromdeforming. In certain embodiments the retractor head is a disc locatedon the external surface of the tongue, in other embodiments theretractor head is an inflatable balloon, in other embodiments theretractor head may have curved parts that act like hooks, in otherembodiments the retractor head may be a flexible wire passing throughthe tissue. In some embodiments it may be totally implanted withintissue.

“Retractor shaft”, “shaft” or “retractor member” refers to that part ofthe tongue retractor that attaches to the retractor head and serves toconnect it to the retractor anchor. In different embodiments the shaftmay be rigid or flexible, solid or hollow, one piece or multiple linkedpieces.

“Unloaded” refers to an LTR that exerts little or no tension. As usedherein this is usually meant as the configuration during the day. Incomparison, the LTR is loaded to therapeutic levels at night.

EXAMPLES 1. Retractor Member (FIGS. 6A-6H)

Disclosed here is a retractor member that is inserted by a needle andautomatically deploys to its working shape.

The retractor head prevents the tongue base from deforming. Thepreferred qualities for a retractor head that rests upon tongue basemucosa are that its depth is minimal so that it is not noticeable to thepatient yet its surface area is large enough to provide sufficientcounterforce. Integral to its design is the delivery device used toinsert the LTR. It is preferable that the entire device be inserted fromthe anterior tongue with minimal instrumentation used at the back of thetongue. Therefore the retractor head preferably automatically deploys toits working shape after being implanted by a needle inserted from thefront of the tongue.

Part of this aspect of the invention includes improvements in the designof the retractor head that allow it to be easily inserted. In certainembodiments this insertion would be by a needle. Therefore oneembodiment of this invention is a retractor head that folds within aneedle but deploys to its working shape after insertion. Many mechanismsare known that allow a device to be minimized for insertion in the body,non-limiting examples include nitinol wire, high pressure balloons, andspring mechanisms. These mechanisms work well but add complexity andunnecessary expense.

In a preferred embodiment the retractor component is oval shaped (10 mmlong, 5 mm wide, 2.5 mm deep) and is molded together with the shaft (1mm) as a single piece from moderate consistency medical grade silicon(Shore 80 durometer, Nusil, Ca) (FIGS. 6A-6D). The retractor is tilted75° in relation to the shaft. When the device is threaded into a needle(6E) one side of the oval extends out of the needle port and projects ata 15° angle relative to the outside wall of the needle. When the needleis inserted through tissue this extension is pushed flush against theneedle wall and causes a minimum increase in the needle's profile (6F).However, immediately after the needle passes through mucosa theretractor reverts to its extended position (6D). In this manner pullingback the needle causes the retractor to catch mucosa and prevents itfrom being withdrawn along with the needle. After the needle is removed,minor tension on the shaft causes the retractor head to rotate intoproper position and lay flush against the mucosa (6G).

The practical advantages of this invention is that the physician canrapidly and easily insert and withdraw the needle and the deviceautomatically settles into its proper position.

2. Shaft Member. (FIGS. 7A-7C)

Disclosed here is a modified shaft that adapts its length to avoidinterfering with normal movements of the tongue base.

The counterforce exerted against the back of the tongue base ispreferably present during sleep but not during the awake state. Morepreferably, the counterforce is present when the tongue is relaxed andvulnerable to posterior collapse, but not during speech and swallowing.During swallowing the tongue base moves rapidly backward about 1 cm tocontact the back wall of the pharynx. The tongue base moves similarlyduring some speech movements, albeit with much less force. It isdesirable that these swallowing and speech movements are not impaired.

In one embodiment of the shaft the section within the tongue isdistensible, one non-limiting example being a balloon. Compression ofthe balloon portion of the shaft allows the shaft to lengthen. Duringswallowing the tongue contracts forcefully around the shaft. Thiscontraction squeezes the balloon and lengthens it, thereby displacingthe retractor head superiorly. As the tongue base moves superiorly inthe area of the retractor head during swallowing, the compressionexerted on the shaft causes the shaft to lengthen proportionally andprevents the retractor head from exerting unneeded counterforce on thetongue base during swallowing. However, the ability to exert the properamount of counterforce when the tongue is relaxed is maintained. Theamount of distensibility is preferably 0.01 to 10 cm, more preferably 1cm.

This embodiment is a preferred but non-limiting example of theinvention. The decrease of counterforce by the retractor head duringswallowing and speech can be accomplished by many mechanical andelectromechanical mechanisms known. Those skilled in the art can readilyappreciate that the invention can have multiple embodiments.

3. Anchor Member: Bolster, Dental, Implanted (FIGS. 8A-8H, 9A-9E, and10A-10C)

Disclosed here are modified anchors that allow reversible loading of animplanted LTR.

The anchor is the anterior component of the LTR that resistsdisplacement of the shaft and retractor head. In a preferred embodimentthe LTR is under little or no tension during the day (unloaded state)and is adjusted to exert tension at night (loaded state). In thisembodiment the anchor merely prevents the anterior end of the shaft frombeing pulled back into tongue tissue. For this purpose a small flange issufficient. However, at night when further retractor counterforce isdesired, the anchor can be replaced, modified, or supplemented;collectively referred to as a modified anchor.

One embodiment of a modified anchor may include a removable adjustmentmember, for example, a bolster that is interposed between the permanentanchor and the tongue (FIGS. 8A-8H), such that, after implantation, theretractor, the permanent anchor, and the bolster are external to thesoft tissue and the flexible shaft maintains a tension between theretractor member and the anchor member to impart a force on the softtissue. This bolster either lengthens the shaft, or if the shaft is setat a fixed length it increases the total volume compressed between theretractor head and shaft. In either case, the addition of the bolster ofthe modified anchor causes a reversible increase in retractorcounterforce, i.e., the bolster adjusts the tension between theretractor member and the anchor. The removable adjustment member mayalso change the surface area of the anchor member as shown in FIGS.8A-8H.

In one embodiment of the modified anchor the bolster is composed ofsilicon gel shaped as a V (FIGS. 8.A, B, and C). The concave innersurface of the ‘V’ adapts to the wedge shape of the frenulum, thestructure underneath the tongue blade. The intent is to spread theretracting counterforce across a wide surface area. In the center of theanchor bolster is a conduit through which the permanent anchor and shaftis threaded. In one embodiment there is a cleft beginning in the centerof the top center edge. This cleft is about the width of the shaft butless than that of the permanent anchor. The patient can reach under thetongue and pull the permanent anchor forward (FIGS. 8.D, E, and F), slipthe bolster under the tongue, lay the shaft into the cleft, and releasethe permanent anchor. The permanent anchor then securely rests againstthe front surface of the cleft and exerts force. The cleft may bereinforced with a harder grade of silicon or another biocompatiblematerial.

Another embodiment of this invention is to secure the permanent anchorto a modified bolster that is permanently or reversibly attached to theteeth, a dental anchor (FIGS. 9A-9E). Many devices that attach to teethare known in the art. A non-limiting example is 2T′ shaped; the topcross bar of the T rests against the front surface of the lower incisorteeth. The initial section of the vertical line of the T is thin enoughto pass between the front two incisor teeth. This vertical part widensto allow the retractor head to be threaded. The final part of the Tnarrows again to about the width of the shaft. This mechanism allows theanchor to be easily and reversibly attached to the dental bolster (FIGS.9.A and B).

Another embodiment is a dental anchor optimized for use on the sides ofthe mouth rather than the front. This embodiment (FIGS. 9.C, D) anchorsto a molar or premolar tooth or neighboring structures. This embodimentis advantageous due to the short distance between the LTR and themodified anchor, its position on the lateral aspect of the tongue isunlikely to interfere with normal tongue function, and it is easilyaccessible for placement, adjustment and removal by patient andphysician.

In a further embodiment a dental prosthesis is used as an anchor thatcouples to LTRs in the soft palate, palatoglossal folds, pharyngoglossalfolds, tongue, or other upper airway sites (FIG. 9.E). These prosthesesare well known in the dental arts, and provide a wide and stableplatform for anchoring embodiments of the LTR. Further embodiments cantake advantage of the large size and position of these prostheses. Thoseskilled in the art can understand that a variety of electrical ormechanical mechanisms could be incorporated within these prosthesis. Asa non-limiting example, an electrical motor could be used to control theforce applied to coupled LTRs at multiple locations in the upper airway.

Still another embodiment of the modified anchor is partially implantedinto the floor of the mouth. In one embodiment of this invention apuncture is made across the frenulum or soft tissue structures of thefloor of the mouth. A flexible shaft is threaded through the punctureand the ends connected to make a ring like structure. This modifiedanchor therefore is securely fixed within tissue while the remainderlies along the floor of the mouth (FIGS. 10A-10C). The modified anchorthen can be reversibly attached to the permanent anchor at night anddisengaged in the morning.

4. Frenulum Area Embodiments

Disclosed are methods and devices for retracting or preventingdeformation of the tongue base by retracting the genioglossus muscle orthe boundary fascia upon which genioglossus muscle inserts (collectivelyreferred to as the frenulum area).

It has been unexpectedly found that the shaft of the LTR can be safelypassed across the undersurface of the tongue. This tissue contains thegenioglossus muscle and its anterior edge is the frenulum (FIG. 11.A,B). The genioglossus muscle originates from the mandible and hasmultiple separate muscle fascicles that fan out from a horizontal tovertical angle. The genioglossus fascicles attach to a layer ofconnective tissue within the tongue called the boundary (FIG. 11.A,dotted line). The genioglossus fascicles normally act by exerting forcein the axis of the fascicle onto the part of the boundary to which theyare attached. However, even when inactive the fascicles are mechanicallycoupled to the tongue boundary and can exert force if passively moved.Unexpectedly, this can be done by pulling these fascicles perpendicularto their axis (FIG. 11.C). To simplify the mechanism, the genioglossusfascicles are lassoed by the LTR shaft.

There are certain important considerations in placing a retractorthrough the genioglossus: First, the genioglossus is soft in comparisonto the tongue base, therefore too much force applied in a localized areacan tear the tissue or cause undesirable tissue remodeling over time,sometimes called the “cheese cutter effect”. However, there is a centraltendon to the genioglossus that is very strong. This tendon is locatedapproximately 1 cm from the edge of the frenulum. Second, the nervesupply to the genioglossus passes along the superior aspect of themuscle, therefore the top 0.5 cm of the muscle, the area directly belowthe tongue blade, is not a preferable site for the implant.

In one embodiment the shaft is a 5 cm length of elastomeric materialthat is ribbon shaped. The cross sectional dimensions are 0.5 mm depthand 3 mm width. The wider dimension of the ribbon will exert force onthe tissue as its force is dispersed over a wider area than the narrowedge of the ribbon. The shaft is attached to a needle and passed throughthe muscle approximately 1 cm behind the frenulum. The ends of the shaftare then reversibly coupled to a modified anchor. The middle section ofthe shaft itself exerts anterior retracting force onto the genioglossusmuscle and acts as a retracting head: one or both ends of the shaft canthen be brought forward and secured to a modified anchor. Thisdisplacement is transmitted to the tongue base causing some degree ofconcavity. The passive movement is preferably in an anterior andinferior direction.

The advantages of genioglossus muscle retraction is that this musclegroup is easily accessible beneath the tongue. The tissue is soft andeasily compressed, making it easy to pierce without complications. Theposition under the tongue is invisible to others, a quality importantfor the patient.

A further embodiment of this invention is to pass the LTR deeper intothe tongue to couple directly to the boundary layer (FIG. 11.D). Theboundary layer is a relatively firm connective tissue structure whichspans the length of the body of the tongue and receives the insertion ofthe genioglossus muscle. The advantages of coupling to the boundarylayer are that it provides a more secure attachment then thegenioglossus itself. However, greater care is needed for placement ofthe device. Specifically the lingual arteries course just superior andlateral to the boundary layer so it is essential that the insertion bemade medial to this structure.

In a further embodiment a fully implanted LTR connects one site thateffects the tongue base and is anchored at another site that does not. Anon-limiting example is shown in FIG. 11E. Here the posterior boundarylayer is coupled to the anterior boundary layer. Tension between the twosites displaces the tongue base forward. Simultaneously there is somedisplacement force exerted around the anterior boundary site but thishas insignificant effects on normal tongue function.

5. Implanted Tongue Base Retractor (FIGS. 12A-12F)

Disclosed here are methods and devices that are implanted within thetongue and exert highly localized forces to prevent mechanicaldecoupling of tongue base structures.

Chronic implants within the tongue are technically challenging andpotentially dangerous. The tongue is a mobile structure and tonguemovements during swallowing and speech are dependent on this mobility.The tongue has no bones within it and its mechanism of movement isunique among the muscular structures of the body. Most skeletal musclesare attached to bones and movement occurs as mechanical levers. In thetongue structures cause movement by expanding and changing their shapeand volume. The mechanism is called a muscular hydrostat and can belikened to a flexible hydraulic system. In addition the tongue hasextensive nerve and blood supply that can be easily damaged. Moreover,the tongue has a tremendous ability to remodel itself when effected byimplants and other forces. This is why many prior art devices havefailed due to gradual loss of tension or extrusion. Moreover any implantis a potential site for infection and scarring. For these reasons anyinvasive intervention in the tongue must be designed with a detailedknowledge of tongue anatomy and physiology.

Therefore the implanted embodiments disclosed in this invention arecarefully designed to be as minimally invasive as possible and to focustheir effects on the most critical areas of pathology without riskinginterference with normal function.

A preferred embodiment of an implanted LTR disclosed here is a veryminimal device implanted into the tongue base.

The tongue is covered by mucosa and this mucosa has underlyingconnective tissue. The connective tissue is thickest below the superiorsurface of the tongue. This superior surface is intimately connected tothe underlying superior longitudinal muscle. Together the mucosaconnective tissue and muscle form a superior layer (SL) that spans thesuperior surface of the tongue from the tongue tip to its base. Thissuperior layer is normally coupled to the underlying middle layer of thetongue which is largely composed by the transverse muscle. Thetransverse muscle originates from a fascial sheet called the medialseptum (MS) oriented in the centerline of the tongue (mid-saggitalplane).

Although not wishing to be bound by theory studies by the inventorsuggest that the vibration during snoring and the stretching duringairway obstruction gradually loosen the attachment of the superior layerto the middle layer. This is reflected by the widening of the superiorlayer in the area of the tongue curve, marked by an oval. Thismechanical decoupling results in a more flaccid and compliant tonguebase that deforms more easily when the pressure in the airway decreases,thereby making the patient susceptible to sleep apnea and other sleepbreathing disorders.

In one embodiment of the invention a very small LTR can be inserted atthe curve of the tongue base to correct the mechanical decoupling of thetongue layers. The LTR is symmetrical with an arrowhead shaped retractorhead and anchor. Each end of the LTR mechanically hooks into softtissue, preferably the connective tissue fascia of the mucosa and themidline septum. The hooking mechanism can be quite varied as manyvariations are known in the art. Non-limiting examples are: hooks,barbs, helixes, staples, screws, sutures, biointegrated permanentmaterial, collagen, and elastin. However, the preferred embodiment is assimple as possible: a short elastic shaft with a hook of firmerconsistency at either end.

In alternative embodiments the implanted LTR can vary from 1 mm to 3 cm.Longer LTRs can couple the tongue base tissue to the boundary fasciabetween the tongue and genioglossus muscle, through the boundary layerto the genioglossus muscle, floor of mouth or mandible via barbs, hooks,fibrotic reaction, or other methods known in the art. The implant can becomposed of biodegradable material that decomposes in a week to a year.Many materials used for surgical sutures can be adapted for thispurpose.

Preferably the shaft is oriented such that the force on the retractor isat least one orientation that includes downward, forward, and to theside. Multiple implants may be used along the midline to distribute thecoupling force without interfering with normal function. Depending onthe anatomy of the patient implants may be inserted at any site in thetongue however, more preferable is the midline of the tongue and mostpreferable is the midline of the tongue curve. One or more of thefollowing aspects of the invention can be used to mold the effects forthe exact needs of the individual patient: implant site and orientation,shaft length and elasticity, and hook size, shape, and hardness.

Preferably the implant is bioresorbable over a period of 1 day to 10years, more preferably 1 month to 1 year, most preferably 1 month to 6months. The most preferable time range allows sufficient time forremodeling of the tongue and persistent if not permanent restoration ofmechanical coupling in the area. Permanent implants are less preferable.

It is preferable that permanent or resorbable implants be inserted intosuperficial levels of the tongue in areas that do not normally undergo agreat amount shape change during normal tongue activity. This minimizesthe possibility of interference with normal function, particularly ifthere is an infection or fibrous reaction to the implant. To plan foratraumatic removal of the implant in cases of infection, pain or othercomplication, the implant should be designed to be easily removedwithout extensive surgery. To facilitate removal of the implant, thetear strength of the hooking mechanism should preferably range from 1 to1000 grams. More preferably 10 to 100 grams. Preferably the arms of thehook would fold straight at these tear strength limits, allowing theimplant to be removed without further damage to tissue as it isextracted.

6. Tongue Base Retraction (FIGS. 13A-13T)

Disclosed here is an embodiment of this invention that focuses onretracting tissue of the tongue base, particularly the tongue basemucosa. This has the advantage that it is easy to insert by thephysician, minimally invasive and easily adjustable by the patient.

In one embodiment the device is inserted from one site to another on thesuperior surface of the tongue. The anterior part of the device is theanchor and the posterior part is the retractor. Tension between the tworetracts the tongue surface and displaces the tongue base. Although thecounter traction affects the anterior tongue surface it has no effect onnormal function.

The shaft either passes directly underneath the mucosa (FIGS. 13A, B) ortakes a more direct line through the tongue (FIGS. 13C, D). Passing theshaft directly underneath mucosa is easier for the physician. In thisconfiguration the force at the retractor head is oriented laterally, andthis causes the mucosa posterior to the retractor head to be pulled tautwith some degree of indentation. In the more direct route the retractionforce is oriented close to perpendicular to the tongue surface and thereis more indentation then mucosal tension. The exact orientation atinsertion can be varied to maximize the beneficial effects for thepatient.

In another embodiment the shaft reemerges in close proximity to theanchor and runs most of its course along the surface of the tongue. Thishas the advantage of avoiding even the minimally invasive tunnels formedby A and B. Furthermore the configurations can be combined and the shaftcan travel the entire distance under the mucosa or can re-emerge one ormore times (FIGS. 13E, F).

In another embodiment the anchor and/or the retractor can be embeddedbeneath mucosa and the shaft is detachable (FIGS. 13G, H). In apreferred embodiment the anchor/retractor would be a silastic disc 5 mmin diameter that is implanted under the mucosa. The disc has a 1 mmdiameter extension that comes out of the pocket. The extension ends in a2 mm disc (FIGS. 13I, J). This extension reversibly couples to a shaft.Preferable shafts would be elastomeric. One preferable embodiment wouldbe a simple medical grade rubber band. Another embodiment is a 1×1 mmstrip of elastomeric material with expansion at either end toaccommodate precut keyholes for attachment to the implantedanchor/retractor. These attachment holes would have 2 mm or greaterinner holes to allow the stretched shaft to pass over the extension and1 mm outer holes or clefts that slot into the extension (FIG. 13K).Materials could be pigmented to match the color of the tongue mucosa. Afurther embodiment would allow the patient to depress the elevatedextension so that it is flush with the mucosa, particularly when not inuse (FIG. 13L). Many mechanisms are known in the art to allow reversibledepression of a button like device.

A further embodiment is an anchor member composed of an elastic sleeveslipped over the tongue blade (FIGS. 13M, N). The shaft may be anintegral part of the sleeve or a separate attachable component. Thesleeve is preferably composed of silicone or other biocompatibleelastomers. The distal end of the shaft can be reversibly attached tothe implanted retractor head. The mechanism by which the shaft andimplant are coupled may include elastic bands, clips, magnets ofopposite polarity, and other mechanisms well known to those skilled inthe art. The advantages of this arrangement are that only a smallpartially embedded implant is needed to achieve retraction.

In a further embodiment two anchors are placed in the PGFs (FIGS. 130,P). The anchors are attachment points for an elastic band passing overthe base of tongue that serves to retract the base, or presses upon asmaller retractor component that is semi-implanted.

In a further embodiment an LTR anchored beneath the tongue blade with ashaft passes through the tongue blade to an intermediate anchor on thesuperior surface of the tongue. The shaft then passes posteriorly to asemi implanted retractor member (FIGS. 13Q, R). This allows adjustmentof tension from the anchor site beneath the tongue blade.

In a further embodiment a rigid shaft connects an anchor member belowthe tongue blade to a retractor member above the tongue blade. Theretractor member is rotated forward by a sleeve that is reversiblyplaced over the tongue blade. The rotation of the retractor member,along with the rigid shaft, displaces the tissue of the tongue basealong the midline (FIGS. 13S, T)

7. Pharyngoglossal Fold (PGF) Embodiments (FIGS. 15A-15F, 16A-16L,17A-17C, and 18A-18F)

Disclosed here are methods and devices for using the PGF as a retractoror anchor site in order to beneficially effect the tongue, pharyngealwalls and/or soft palate.

On both sides of the tongue thin folds of mucosa connect the tongue tothe mandible. These are called the pharyngoglossal folds (PGF). Withinthese folds are the palatoglossal, superior constrictor, styloglossusand hyoglossus muscles, from superior to inferior respectively. The PGFsseparate the oral cavity (anterior) from the pharynx (posterior).Anterior to this attachment there is no lateral connection of the tongueand it is freely mobile. One of the muscles within the PGF is thepalatoglossus which courses superiorly to connect with the soft palate,thereby forming what is seen in the mouth as the anterior tonsillarpillar.

Unexpectedly the PGF has been found to have several advantages as aretraction site that enlarges the pharyngeal airspace. The correctivetissue of the PGF is connected with that of the tongue. Therefore, ithas been unexpectedly found that traction on the PGF is transmitted tothe base of tongue. Moreover, as the superior pharyngeal constrictor andpalatoglossus muscles are attached to the PGF and in turn connect withthe lateral pharyngeal walls and soft palate these structures can alsobe retracted (FIGS. 14A-14E). In particular a preferred site within PGFis its superior end where many of these muscles overlap as they insertinto the tongue. Therefore retraction at one site expands the pharyngealairway by simultaneously stiffening and/or retracting the tongue base,lateral pharyngeal walls and soft palate. All of these effects have abeneficial effect on sleep disordered breathing.

A further advantage of the PGF is that it is easily accessible to boththe physician and patient. The PGF is not normally seen duringexamination of the mouth as it is in a folded state and hidden by thetongue surface above it. However, the PGF can be easily palpated bysliding a finger along the floor of the month next to the mandible, atthe level of the edge of the mandible a smooth vertical wall is reachedwhich blocks entry into the pharynx; this is the PGF. To visualize thePGF the tongue can be retracted medially with a tongue blade.

A further advantage of the PGF is that it does not have a lot of sensoryinnervation. The area of the mouth around the PGF is highly sensitive.Specifically, the tonsillar pillars and the tongue surface next to thePGF are the most sensitive areas of the upper airway that cause reflexgagging. However, it has unexpectedly been found that touching the PGFitself causes little or no gagging. Moreover, even the small amount ofsensation caused by touching the PGF disappears within minutes.

A further advantage of the PGF is that it is thin and easy to punctureyet contains enough connective tissue to provide a firm interface with aretractor. Anatomical studies by the inventor have shown that the PGFhas few neurovascular structures and is 1-3 mm in thickness. Thereforeany piercing or puncturing of the PGF is safe.

The invention consists of using an LTR to displace the PGF orneighboring tissue.

The most preferable retraction would be in an anterior direction as theretraction displaces the entire base of tongue anteriorly therebyincreasing the retroglossal and retropalatal airspace. Also preferableis inferior retraction of the PGF as this displaces the tongue baseinferiorly thereby removing tissue volume from the retropalatal area,the narrowest part of the upper airway. Lateral retraction would stiffenand flatten the posterior surface region of the tongue base. Lesspreferable is posterior or medial retraction.

This retraction could be unilateral but is preferably bilateral. Thisretraction could be acute, just during an obstructive episode, or semiacute, overnight while sleeping, or for extended durations. Extendeddurations of retraction would cause tissue remodeling that would causethe tongue to tend to remain in a more anterior position even withoutany force applied.

In one embodiment an LTR is inserted across the PGF and passes acrossthe frenulum to attach to a similarly implanted LTR on the opposite side(FIG. 15B).

In one embodiment the retractor lays against the PGF but the shaftpasses through the tongue (FIG. 15C) to an external anchor.

In one embodiment the retractor is implanted within the PGF orneighboring tongue tissue and passes anteriorly and inferiorly to animplanted anchor in the tongue, genioglossus muscle, and/or floor ofmouth (FIG. 15D).

In one embodiment the retractor is implanted against the superior PGFand the shaft passes inferiorly through or outside the PGF to an anchorthat is implanted against the same PGF either on the same or oppositeside (FIG. 15E). This method retracts the superior PGF in an inferiordirection.

In a further embodiment against the PGF and the shaft passes mediallyand superiorly to an anchor on the superior surface of the tongue (FIG.15F).

In a further embodiment the retractor is implanted at the tongue baseand connects to two shafts that are placed at either PGF (FIGS. 16C, D).

In a further embodiment a shaft placed beneath the mucosa of the tonguebase connects retractor members anterior to each PGF (FIGS. 16E, F).

In a further embodiment, a shaft placed beneath the mucosa of the tonguebase is connected at either end to implanted magnets in or around thePGFs (FIGS. 16G, H). External modified anchors with magnets of oppositepolarity are used to bond to the implanted magnets and anchor them toexternal structures.

In a further preferred embodiment, only the retractor member would beimplanted in the PGF. The retractor would have a flange surface near itsposterior aspect that would provide the interface against the PGF tocause anterior retraction. A second flange could be added anteriorly toprevent displacement of the conduit. A variety of coupling mechanismscould be used, Figure (FIGS. 16I, J) shows a magnetic mechanism.

Magnets are implanted within each PGF and external modified anchors withmagnets of opposite polarity are used to bond to the implanted magnetsand anchor them to external structures. Many other coupling mechanismsare known in the art, non-limiting examples being hooks, clamps orscrews. This embodiment is minimally invasive and allows the patient avery high degree of comfort during the day when the implant isunconnected and therefore unloaded. A variety of different shaft andanchor combinations can be tested without needing to replace theretractor implant.

Another aspect of this invention is a lateral dental anchor. This anchormay couple to the LTR using magnets, or mechanical mechanisms known inthe art. The advantage of this device is that the PGF is very close tothe mandibular teeth, and a secure but reversible loading of theimplanted LTR can therefore be achieved with short devices. Moreover,the route from the PGF to the molar teeth is unlikely to cause thepatient significant discomfort.

In still another embodiment of this invention anchors coupled to one ofthe following non-limiting list of structures inserts into retractors onor lateral to the PGF or pass through the PGF to tongue structures: thestyloglossus, hyoglossus, chondroglossus, pharyngeal constrictor,levator and tensor of the palate, masetter, temporalis, pterygoid,facial, and platysma muscles; the hyoid, mandible, facial, and vertebralbones; the thyroid, cricoid, epiglottic cartilages; the stylohyoid,ptyrogomandibular ligaments and other fascial structures.

8. Soft Palate And Tonsillar Folds

Disclosed here are methods and devices for retracting the lateralpharyngeal walls and soft palate.

FIGS. 17A-17C show the basic anatomy of the internal soft palatestructures and some embodiments of this invention. The soft palate is athin muscular structure that separates the nasopharynx and velopharynxfrom the oral cavity. It begins at the edge of the hard palate andextends downward toward the throat. In the midline it ends at the uvula,and on each side it divides into two folds that surround the palatinetonsils: the anterior tonsillar fold, also called the palatoglossalfold, inserts into the side of the tongue near the superior PGF; theposterior tonsillar fold, also called the palatopharyngeal fold, insertsinto the lateral pharyngeal wall.

Excess length or thickness of the soft palate decrease the volume of thevelopharynx and contribute to snoring and sleep apnea. In addition,laxity of the soft palate, and pharyngeal walls predisposes to airwaycollapse. The methods of this invention can reversibly or persistentlythin, stiffen, and/or retract the soft palate and pharyngeal wallstructures.

The loading of a soft palate LTR is analogous to the above describedembodiment in the tongue. Specifically the soft palate LTR could rest inplace unloaded, i.e. with a minimum tension (preferably 1-100 gms, mostpreferably 5-15 gms) that is sufficient to keep the shaft within tissueand the anchor and retractor resting immobile against mucosa. Thepatient would therefore have little or no sensation of the LTR'spresence At night the LTR could be loaded by placement of a modifiedanchor, non-limiting examples being a bolster between the anchor and themucosa, or connecting to a dental device.

The exact site and orientation of the lateral LTR has a great influenceon whether the effects of the LTR are primarily to compress or displacetissue.

FIGS. 17A-17C show some non-limiting examples of the same anchor site atthe superior PGF can have multiple preferred embodiments with differentbeneficial effects:

LTR #1 in the figure is oriented to achieve inferior displacement of thelateral aspect of the soft palate, thereby enlarging the velopharynx.

LTR #2 passes to the midline of the soft palate. The exact location,force and number of LTRs can be varied in order to best treat thespecific pathology of each patient.

LTR #3 passes across the tonsil to a retractor on the pharyngeal side ofthe posterior tonsillar pillar. The tonsils in sleep apnea patientsoften are enlarged relative to normal and this enlargement contributesto the excess soft tissue of the upper airway. Tension in the shaftwould compress the tonsils and decrease their volume.

LTR #4 passes from the superior PGF to the mucosa of the tongue base.This embodiment stiffens the mucosa of the tongue base and prevents thetongue base from deforming backward.

FIGS. 18A-18F show a variety of preferred embodiments in the tonsillarfolds.

FIGS. 19A and 19B show an embodiment of a midline LTR in the soft palatewith an anchor near the hard palate, a shaft passing through soft tissueand a retractor head in the uvular area (FIG. 18A). The anchor elementcould rest against the mucosa on either the oral side or pharyngealside. The anchor would be available to couple to a modified anchor onthe oral side such as a dental appliance, or a modified anchor on thepharyngeal side. The retractor member could be inserted so it faceseither forward, downward or backward.

FIGS. 19C-19F show the effect of a modified anchor in bolster form onthe shape and position of the soft palate. Inserting a bolster rotates,stiffens and indents the soft palate. All of which serve to decrease thesusceptibility to snoring and airway obstruction. The mount of tensionadded by the bolster preferably ranges from 1 to 500 gm, more preferably5 to 250 gms and most preferably 10 to 50 gms. The bolster is designedto allow the anchor head to fit into a recess in the front surface, suchthat after insertion the combined anchor bolster presents a smooth andsoft continuous surface thereby having no effect on speech or swallowingand causing minimal discomfort to the patient.

FIGS. 19G and 19H show another preferred embodiment of the LTR which istotally implanted.

FIGS. 19I and 19J show a further embodiment whose main effect is tocompress a thickened soft palate. The anchor and retractor componentsare aligned on either side of the soft palate. Tension in the shaftcompresses and thins the tissue between them.

FIGS. 19K and 19L show an embodiment in which restraining shafts areanchored by the LTR and pass around the edge of the soft palate to keepthem in position.

9. Veterinarian Embodiments (FIGS. 20A-20G)

Disclosed here are methods and devices to treat sleep apnea and relateddisorders in mammals.

A non-limiting example of a non-human upper airway disorder is dorsaldisplacement of the soft palate (DDSP) in horses. Race horses are superbanimal athletes that place the greatest demands on respiration. Allnon-human mammals have a different configuration of their upper airways.Specifically the soft palate and larynx are much closer and they usuallyinterlock (FIG. 20A). Specifically the soft palate is firmly held aroundthe epiglottis of the larynx so that the airway from the nose throughthe pharynx and into the lungs is protected and secure. In race horsesthis is of special importance because of the tremendous volume of airthat must smoothly flow into and out of the lungs with each breathduring exercise.

In some horses this interlocking of the soft palate and epiglottisbreaks down and the soft palate passes backward over the epiglottis(20B). This displacement of the soft palate immediately interferes withbreathing and the animal stops running. Although the cause of DDSP isnot known with certainty many trainers believe that the tongue causesthe displacement by moving backward and pushing the soft palate out ofposition. For this reason many trainers actually tie the race horse'stongue forward prior to the race, a solution that is crude anduncomfortable for the animal.

Part of this invention are methods and devices to prevent DDSP both bypreventing backward displacement of the tongue and by securely couplingthe soft palate to the epiglottis. In humans the conditions surroundingsleep disordered breathing involve a relaxed tongue during sleep. Inhorses the situation is quite different: the tongue and other upperairway structures are much larger and maximally active. Therefore theLTR must be adapted to these harsher conditions. Moreover secureprevention of backward movement of the tongue does not allow normalswallowing. Therefore it is necessary that the LTR be loaded immediatelybefore exercise and unloaded immediately afterward. Moreover this needsto be done by the trainer, with or without the cooperation of the horse.

In one embodiment an LTR is used to prevent movement of the tonguebackwards to prevent dorsal displacement of the soft palate in a horse.The situation in the equine patient differs in many substantial waysfrom that of the human. The problem occurs when the animal is awake andexercising at frill capacity. It is believed that the tongue movesbackward and pushes the soft palate out of its normal position where itis interlocked with the epiglottis (K). Therefore the retracting forcesneeded are much higher than those used in humans (preferably 1 gm to 50Kgms, more preferably 10 gm to 10 Kgm, most preferably 100 gm to 1 Kgm).To accommodate these forces the LTR materials are preferably composed ofstainless steel or materials of comparable tensile strength. In oneembodiment an LTR passes from the tongue base to the superior surface ofthe tongue. The LTR is unloaded most of the time and only becomes ladedwhen it is connected to the bit of the horse's bridle prior to exercise.In a further embodiment the LTR spans from the tongue base through themandible where is can be accessed inside of the lip. A bolster is placedto load the LTR prior to exercise.

FIG. 20D shows an embodiment of the LTR that takes advantage of certainunique circumstances present in horses. Specifically, a bridle isusually placed on the horse's head when racing to control the horse, andmost bridle's have a bit, a bar which passes across the horse's mouth.This bit can be used as a modified anchor to couple and load the LTR.

Alternative embodiments secure the soft palate and epiglottis together.FIGS. 20E and 20F an embodiment wherein LTR passes from the soft palateto the epiglottis to resist displacement, and if it occurs, to rapidlyrestore the interlocked configuration. FIG. 20G shows an embodimentwhere an LTR from each PGF attaches to the lateral aspects of each softpalate.

10. Non-Invasive Embodiments (FIGS. 21A-21H, 22A-22H, and 23A-23K)

Disclosed here are methods and devices for non-invasively retractingmucosa and displacing soft tissue volume for the treatment of sleepapnea and related disorders. A major advantage is that no surgicalprocedure is needed, and non-invasive devices can be easily inserted andremoved by the patient.

At present the only effective non-invasive therapy for sleep apnea isCPAP. CPAP displaces the soft tissue with air pressure and, althougheffective in many cases, it is uncomfortable for the patient and has avery low compliance rate. The only other non-invasive therapies whichhave some effect on sleep apnea are the dental devices. Dental deviceswork by moving the jaw down and forward, thereby indirectly moving theentire floor of mouth and tongue. By this method the airway is expandedand the mucosa connecting the jaw to the pharynx is slightly stretchedand stiffened. Unfortunately the joint connecting the jaw to the skullcan only be stretched a small amount so that there is a limit to howmuch the airway can be expanded. Therefore, at present, dental devicesare only effective in some mild cases.

It is not obvious how any LTR could retract the tongue and other softtissue without puncturing, mucosa. The tongue and pharynx are highlysensitive to contact and any stimulation causes gagging. Moreover, thewhole region is covered with slippery mucosa and is always moving.Therefore it is not obvious that a device can remain in place withoutsome firm anchoring to tissue.

In one embodiment a retractor ‘hooks’ the PGF much like eyeglasses hookover the ear (FIGS. 21B and C). The retractor lies within the grooveformed by the base of tongue and the lateral pharyngeal wall with itsmain contact along the vertical back surface of the PGF. In oneembodiment the retractor is preferably thin, soft and form fitted tocomfortably distribute force to the mucosa. A non-limiting example is asoft gel like silicone. The length of the retractor is preferably 1 mmto 100 cm, more preferably 0.5 cm to 5 cm, most preferably 1 cm to 2 cm.The retractor can extend downward as far as the esophagus and in someembodiments retract the upper esophageal sphincter, the pyriformsinuses, the vocal folds, the aryepiglottic folds, the epiglottis and/orthe lateral pharyngeal walls.

Another preferable shape for the retractor is a wedge shape as shown inFIG. 21H. The wider plane of the wedge would preferably be 1-10 mm wide.This width compresses the tongue base and decreases its compliance,thereby helping to prevent its posterior collapse. The wider base canthen also coax the tongue base anteriorly (FIGS. 21G and H).

In some embodiments the shaft passes directly from the top of theretractor over the PGF to connect with one or more of the anchoringsites disclosed herein. The closest structures are the teeth andparticularly the molars. Dental appliances that are affixed to molarsare well known in the art. These appliances can have a wide variety ofmechanisms to attach to the shaft. One common method similar to thatused in orthodontics is to use rubber bands. In this case a rubber bandwould attach to the retractor at one end and the anchor on a molar toothat the other. The advantage of this embodiment is that the device iseasily removable and replaceable, completely adjustable, and thedistance traveled by the shaft to anchor could be very short, therebyachieving the goal with minimal patient discomfort.

The hook retractor can be used at many sites disclosed herein. However,to remain in place the hook requires that it be loaded while inposition. The PGF site is advantageous as the retractor is surrounded bytissue on all sides and even the top is covered by the overhanginglateral part of the tongue.

In another preferred embodiment of this invention the retractor isdesigned to remain attached to the tissue fold indefinitely bynon-invasive means. In one preferred embodiment the mechanical retractoris clipped over the tissue fold so that it can remain in place forextended periods without connection to an anchor (FIGS. 22A-22H). Tissuefolds are malleable such that compression at the ends of the clipsindents the tissue and resists its migration out of position (22A).Compressive force at the ends of the arms of the clip would preferablybe mechanical. These forces may be generated by the plastic physicalproperties of the clip, a spring incorporated at its lower end, aninserted length of nitinol or other material that maintains force, or bymagnets within the anchor/retractor components (22B). Magnets can alsobe used to reversibly couple to a modified anchor. This embodiment canboth compress the mucosa and retract the edge of the soft tissue fold(22C). Two clips can be connected by a shaft that is exerting force inan expanding direction (protract or lengthen) (22D).

The clip non-invasive retractors can be used in all sites within theupper airway where mucosal folds are present or where they can be formedby grasping tissue. These include without limitation, the PGF, frenulum,lateral tongue surface, tonsillar folds (22E, F), soft palate (22G),pharyngeal walls, floor of the mouth, and aryepiglottic fold. Some ofthese sites have extensive sensory innervation, however, so long as thecontact between the clip and mucosa is stable and immobile the sensationdisappears within minutes. This loss of sensation is called habituationand is well known to sensory physiologists. The stability of theretractor to mucosa contact is increased by the use of adhesives knownin the art. Adhesives effective on mucosa include but are not limited tofibrin, hydrogels, and/or cyanoacrylic glues. It is also important thatthe site for the clip as well as the shaft and anchor be placed suchthat the least amount of dynamic contact occurs between components andmucosa. In addition, for persistent use the compression between the armsof the clip should not exceed the pressure at which capillary bloodcirculation stops, called the perfusion pressure, which is about 25 mmHg or 34 cm H2O.

Another non-invasive embodiment of this invention are methods anddevices that use a vacuum to retract or displace soft tissue. Vacuumdevices are used in two different methods: a vacuum can serve to suck aretractor head onto a mucosal surface thereby attaching the retractor;the vacuum can be applied over a larger segment of the tongue and causedisplacement of tongue tissue into the suction. As the volume of thetongue is constant the displacement of tissue must come from other partsof the tongue, most preferably the tongue base.

In one method a vacuum is used to couple a retractor to mucosa. Then theretractor can be attached to modified anchors as described herein. Asecond method of using a vacuum is to displace soft tissue volume. Thisis preferably used on the tongue by a relatively larger device thatsucks tissue volume into the vacuum device and thereby changes the shapeof the tongue such that volume is removed from the tongue base.

The vacuum retractor could be a suction cup type well known in the artand the vacuum formed by pressing against the mucosa. Preferably theinterface between device and mucosa has well defined edges with interiorwalls at 90° or greater. This embodiment suctions small amount s oftissue into the opening and their presence provides resistance to shearforces acting at the suction site (23J). The vacuum retractor could alsobe connected to a vacuum source via a tube leading from the vacuumretractor out of the mouth. In another embodiment a small air pump couldbe located in the mouth. This pump may be passive, composed of a smallbladder with a one way valve such that movements of the tongue or jawthat compress the bladder force air out of it through the one way valve.The elastic drive of the bladder to return to its larger volume shapeforms the vacuum.

After the vacuum retractor couples to the mucosa it can be displacedforward by a shaft similar to those used for the other embodiments. Thevacuum retractor could be a single suction interface or multiple smallerinterfaces; mini suction cups. Viscous mucoid material or adhesive couldbe applied to the mucosa to aid in maintaining a seal. The vacuumretractor is most preferably applied to the anterior surface of the PFG.Other preferred sites are the lateral and inferior tongue surface. Thoseskilled in the art can understand that the vacuum could be applied atall locations that retraction is beneficial.

Another embodiment of this invention is to increase the pharyngealairspace by depressing the floor of the mouth. The floor of the mouth(FOM) is composed of muscles and other soft tissue that attaches to thehyoid posteriorly and the mandible anteriorly and laterally. The tonguesits on the FOM and follows its movements. For example when the jaw ismoved forward or downward the tongue moves along with it. Similarly whenthe hyoid bone moves forward it displaces the back of the tongue in thesame direction. Some surgical procedures try to take advantage of thisrelationship by wiring the hyoid bone in a more forward position bywiring it to the front of the mandible. Unfortunately the hyoid bone hasmany other attachments that resist being repositioned.

This invention does not focus on moving the boney attachments of the FOMbut instead on moving the soft tissue of the FOM itself. Specifically,the bottom of the tongue (root of the tongue) that rests on the FOM istriangular shaped and smaller than the overall area of the FOM (FIGS.23A-23K). Therefore the FOM can be reached between the tongue root andthe mandible. When this area is depressed the root of the tongue isdepressed as well. Although the entire exposed FOM can be depressed,this is inefficient, as the most important area to move is the tonguebase.

In the preferred embodiment the area of the FOM around the tongue baseis depressed thereby moving the tongue base down and increasing thepharyngeal airspace. For practical purposes the PGF places a limit onhow far back the FOM can be reached. In one embodiment an LTR with asilicon bolster of 0.5 cm×0.5 cm×1 cm is situated longitudinallyalongside the undersurface of the tongue with one end abutting the PGF.Downward pressure is achieved by a dental appliance attached to themolar teeth. Not all of the downward movement of the local area of FOMdepression is transferred to the tongue. However, any significantincrease in the pharyngeal airspace is beneficial.

In addition to depression of the FOM, displacement force can be exertedforward (anterior), inward (medial) or outward (lateral). Forwarddisplacement is beneficial because the pharyngeal airspace is expandedto the extent that the tongue base also moves forward. Inward movementis beneficial if both sides exert a grasping force on the tongue andthereby resist its backward collapse. Outward movement is alsobeneficial to the extent that it stretches and tenses tongue tissuethereby also preventing backward collapse.

It is to be understood that the exemplary embodiments are merelyillustrative of the invention and that many variations of theabove-described embodiments can be devised by one skilled in the artwithout departing from the scope of the invention. It is thereforeintended that all such variations be included within the scope of thefollowing claims and their equivalents.

1. A method of treating a breathing disorder, the method comprising:providing a tissue retractor comprising: a shaft having a first end anda second end; an anchor member attached to one of the first end or thesecond end; and a retractor member attached to the other of the firstend or the second end; and inserting the shaft through a soft tissue ofa patient's soft palate; wherein the tissue retractor distributes aforce on the soft palate thereby changing a size, a stiffness, and/or ashape of the patient's soft palate and preventing obstruction of thepatient's airway.
 2. The method of claim 1, wherein the force thins thepatient's soft palate.
 3. The method of claim 1, wherein the forceretracts and shortens the patient's soft palate.
 4. The method of claim1, wherein the force stiffens the patient's soft palate.
 5. The methodof claim 1, wherein the tissue retractor is positioned along themid-line of the soft palate.
 6. The method of claim 1, wherein theanchor member is positioned on an exterior surface of the soft palate onone of an inferior oral side of the soft palate and a superiorpharyngeal side of the soft plate and the retractor member is positionedon the exterior surface of the soft palate on the other of the inferiororal side of the soft palate and the superior pharyngeal side of thesoft plate.
 7. The method of claim 1, wherein the anchor member ispositioned at one of an end of the soft palate adjacent the patient'shard palate and an end of the soft palate adjacent to or in the uvulararea, and the retractor member is positioned at the other of an end ofthe soft palate adjacent the patient's hard palate and an end of thesoft palate adjacent to or in the uvular area.
 8. The method of claim 1,wherein the anchor member is positioned on an exterior surface of aninferior oral side of the soft palate at an end of the soft palateadjacent the patient's hard palate, the shaft passes through the softpalate, and the retractor member is positioned on an exterior surface ofa superior pharyngeal side of the soft palate in the uvular area.
 9. Themethod of claim 1, wherein the anchor member is positioned on anexterior surface of a superior pharyngeal side of the soft palate at anend of the soft palate adjacent the patient's hard palate, the shaftpasses through the soft palate, and the retractor member is positionedon an exterior surface of an inferior oral side of the soft palate inthe uvular area.
 10. The method of claim 1, further comprisingconnecting a removably attachable adjustment member to the tissueretractor, wherein the attachment of the adjustment member changes theforce that is provided to the soft palate by the tissue retractor,rotates the soft palate, or indents the soft palate.
 11. The method ofclaim 10, wherein the adjustment member is a bolster disposed betweenthe anchor member an external surface of the soft palate.
 12. The methodof claim 11, wherein the bolster includes a recess to accommodate theanchor member such that, after connection of the anchor member to thebolster, the combination of the anchor member and the bolster has asmooth and continuous surface.
 13. The method of claim 10, wherein theanchor member is positioned on the inferior oral side of the softpalate.
 14. The method of claim 1, further comprising attaching theanchor member to a connection member located in the oral cavity of thepatient.
 15. The method of claim 14, wherein the anchor member ispositioned on the inferior oral side of the soft palate or the superiorpharyngeal side of the soft palate.
 16. The method of claim 14, whereinthe connection member is a dental appliance.
 17. The method of claim 1,wherein the shaft extends through the soft palate in a directionextending from an area adjacent the hard palate to an area adjacent thepharynx.
 18. The method of claim 1, wherein the anchor member and theretractor member are aligned on opposite sides of the soft palate suchthereby compressing and thinning the soft tissue of the soft palate. 19.The method of claim 1, wherein the tissue retractor is totally implantedwithin the soft tissue of the soft palate.
 20. The method of claim 1,further comprising at least one restraining shaft connected to theanchor member and the retractor member, wherein the restraining shaftpasses around an exterior edge of the soft palate to maintain theposition of the anchor member and the retractor member with respect tothe shaft and the soft palate.